Hemp Oil by Manitoba Harvest

POSSIBLY INEFFECTIVE

• Hyperlipidemia. Clinical research suggests that alpha-linolenic acid does not lower lipid levels in adults with hyperlipidemia. Details: A meta-analysis of 20 small clinical trials in patients with hyperlipidemia shows that taking foods or supplements containing alpha-linolenic acid does not reduce lipid levels when compared with control (104256). The findings from this analysis are limited by the heterogeneity of the alpha-linolenic acid supplementation regimens and patient populations.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Atherosclerosis. Some research suggests that increasing dietary alpha-linolenic acid intake may decrease atherosclerosis. Details: Epidemiological research in White adults has found that high dietary intake of linolenic acid is associated with reduced calcified atherosclerotic plaques in the coronary arteries. Most dietary linolenic acid is alpha-linolenic acid (only a small fraction is gamma-linolenic acid). For every gram of linolenic acid consumed, risk of coronary artery calcification appears to decrease by 62% (12990). The effects of linolenic acid intake in other populations are unclear.
• Atopic dermatitis (eczema). Although there is interest in using oral alpha-linolenic acid (ALA) for atopic dermatitis, there is insufficient reliable information about the clinical effects of ALA for this condition.
• Attention deficit-hyperactivity disorder (ADHD). It is unclear if alpha-linolenic acid is beneficial in patients with ADHD. Details: Small clinical trials show that taking alpha-linolenic acid does not improve symptoms of previously untreated ADHD in children aged 6-16 years. Taking alpha-linolenic acid 1 gram daily for 8 weeks, or taking a combination of alpha-linolenic acid 60 mg, linoleic acid 240 mg, mineral oil 95 mg, and alpha-tocopherol 5 mg twice daily for 7 weeks does not affect ADHD symptom scores when compared with placebo (100660,100661). However, these studies might have been inadequately powered to detect a difference between groups.
• Cancer. It is unclear if increased dietary intake of alpha-linolenic acid affects mortality in patients with cancer. Details: A large meta-analysis of prospective, observational studies has found that high dietary intake of alpha-linolenic acid is associated with a 6% increased risk of mortality from cancer when compared with low dietary intake of alpha-linolenic acid (106661).
• Cardiovascular disease (CVD). Population research has found that increased dietary intake of alpha-linolenic acid may have some benefit for CVD, but results from clinical research are generally less positive. Details: A large meta-analysis of prospective, observational studies has found that high dietary intake of alpha-linolenic acid is associated with an 8% or 11% reduced risk of mortality from CVD or coronary heart disease (CHD), respectively, when compared with low dietary intake of alpha-linolenic acid. A dose-response analysis and meta-analysis show that a 1-gram increase in daily dietary intake is associated with a 5% reduction in CVD mortality (106661,107741). Other population research has found that consumption of 1-2 grams of dietary alpha-linolenic acid daily is associated with a reduced risk of a first myocardial infarction (MI) by as much as 59% in both males and females (7152,7156). The risk of fatal ischemic heart disease is reduced by 65% in females (7153). In patients who have had a previous MI, following a Mediterranean diet rich in alpha-linolenic acid (1.2-1.6 grams daily) and low in saturated fat and cholesterol for 27 months appears to reduce the risk for a second MI by 73% and the risk for death from any cause by 70% when compared to the standard postinfarction diet (7150). Overall, increasing dietary intake of alpha-linolenic acid by 1-1.2 grams daily appears to reduce the risk of fatal coronary heart disease by 20% in people with no history of heart disease and by 20% or more in people with existing heart disease (12978,91403). However, clinical research has not supported these findings. A meta-analysis of a small number of low to moderate quality clinical studies shows that higher intake of alpha-linolenic acid has little to no benefit for primary prevention of CVD, and does not reduce all-cause mortality, CVD mortality, or CHD events. Any reductions in CVD mortality, arrhythmias, or CHD events in individual trials are very small (103955). This may be due in part to the difficulty in separating the effects of alpha-linolenic acid from those of other dietary, lifestyle, or drug interventions (12917). Some research suggests alpha-linolenic acid has a greater effect on coronary heart disease when intake of fish oils is low (12989).
• Chronic obstructive pulmonary disease (COPD). Although there is interest in using oral alpha-linolenic acid (ALA) for COPD, there is insufficient reliable information about the clinical effects of ALA for this condition.
• Cognitive function. It is unclear if oral alpha-linolenic acid improves cognitive function in healthy adults.
• Crohn disease. Although there is interest in using oral alpha-linolenic acid (ALA) for Crohn disease, there is insufficient reliable information about the clinical effects of ALA for this condition.
• Crohn disease. Although there is interest in using oral alpha-linolenic acid (ALA) for Crohn disease, there is insufficient reliable information about the clinical effects of ALA for this condition.
• Depression. It is unclear if oral alpha-linolenic acid is beneficial in patients with depression. Details: Clinical research in patients aged 60-80 years who have had a myocardial infarction shows that consuming margarine containing alpha-linolenic acid 2 grams daily for 40 months does not reduce symptoms of depression when compared with placebo margarine (104978).
• Diabetes. It is unclear if oral alpha-linolenic acid is beneficial in patients with diabetes. Details: Epidemiological research involving overweight and obese individuals has found that eating at least 1.69 grams alpha-linolenic acid daily is associated with a 45% to 47% reduced risk of developing type 2 diabetes when compared with eating only 0.73 grams daily. However, higher intake of alpha-linolenic acid does not appear to be associated with a reduced risk of diabetes in people who are not overweight (101025). In patients with diabetes, epidemiological research shows that lower intake of alpha-linolenic acid is associated with an increased risk of diabetic nephropathy (101024). However, a meta-analysis of clinical research in adults with diabetes who are stable on oral antidiabetic medications shows that adding alpha-linolenic acid 1.5-7.4 grams daily, in the form of flaxseed oil, walnuts, or chia seeds, to a regular diet for 2-12 months does not improve glycemic control when compared with placebo (98002).
• Influenza. Although there is interest in using oral alpha-linolenic acid (ALA) for influenza, there is insufficient reliable information about the clinical effects of ALA for this condition.
• Hypertension. Some research suggests that increasing dietary alpha-linolenic acid may decrease the risk of hypertension. Details: Epidemiological research has found that high dietary intake of linolenic acid is associated with a reduced risk of hypertension in White adults. Most dietary linolenic acid is alpha-linolenic acid (only a small fraction is gamma-linolenic acid). Eating a diet high in linolenic acid seems to reduce the risk of hypertension by about 33% (12991). The effects of linolenic acid intake in other populations are unclear.
• Kidney transplant. Observational research suggests that alpha-linolenic acid is not beneficial after a kidney transplant, and may actually increase the risk of mortality. Details: Epidemiological research has found that dietary intake of alpha-linolenic acid is not associated with improved graft function in kidney transplant. However, kidney transplant recipients in the highest tertile of alpha-linolenic acid intake appear to have a 2.2-fold increased risk of death from any cause when compared with those in the lowest tertile of dietary intake (98003). It is not clear whether this difference is specifically due to alpha-linolenic acid intake or to total fat intake.
• Migraine headache. Although there is interest in using oral alpha-linolenic acid (ALA) for migraine headache, there is insufficient reliable information about the clinical effects of ALA for this condition.
• Multiple sclerosis. Although there is interest in using oral alpha-linolenic acid (ALA) for MS, there is insufficient reliable information about the clinical effects of ALA for this condition.
• Overall mortality. It is unclear if increased dietary intake of alpha-linolenic acid affects all-cause mortality. Details: A large meta-analysis of prospective, observational studies has found that high dietary intake of alpha-linolenic acid is associated with a 10% reduced risk of all-cause mortality when compared with low dietary intake of alpha-linolenic acid. A dose-response analysis shows that a 1-gram increase in daily dietary intake is associated with a 5% reduction in overall mortality (106661). However, a meta-analysis of 250,000 individuals did not find an association between dietary alpha-linolenic acid intake and all-cause mortality (107741). The validity of this finding is limited by the use of dietary surveys to assess intake and the heterogeneity of the included studies.
• Prostate cancer. There is contradictory evidence about the role of alpha-linolenic acid in prostate cancer. Details: Some epidemiologic research suggests that high dietary intake of alpha-linolenic acid is associated with an increased risk for prostate cancer (1337,2558,7823,7147,12978). Other research suggests high intake or serum levels of alpha-linolenic acid is not associated with increased levels of prostate specific antigen (PSA) or the overall risk of prostate cancer (12961,15736,91402). However, it might increase the risk of advanced prostate cancer (12961). The best evidence to date, which comes from a meta-analysis of five prospective population studies, suggests that increasing intake of alpha-linolenic acid by 0.5 grams daily is associated with a modest 1% reduction in the risk of prostate cancer. However, this analysis is dominated by a single study. A meta-analysis of results from nine prospective population studies suggests that a 0.1% increase in blood levels of alpha-linolenic acid is not associated with prostate cancer risk (90677). Reasons for the discrepancies are not entirely clear, but the source of alpha-linolenic acid appears to be important. Alpha-linolenic acid from dairy and meat sources has been positively associated with prostate cancer. Alpha-linolenic acid from plant sources, such as flaxseed, may not affect prostate cancer risk (12909).
• Pneumonia. It is unclear if dietary alpha-linolenic acid reduces the risk for pneumonia. Details: Epidemiological research has found that increasing dietary alpha-linolenic acid consumption is associated with a reduced risk of community-acquired pneumonia (13760).
• Psoriasis. Although there is interest in using oral alpha-linolenic acid (ALA) for psoriasis, there is insufficient reliable information about the clinical effects of ALA for this condition.
• Respiratory tract infections. It is unclear if oral alpha-linolenic acid is beneficial for reducing the incidence of respiratory tract infections in children. Details: Preliminary clinical research in children aged 3-4 years shows that taking alpha-linolenic acid 855 mg, in combination with linoleic acid 596 mg daily from November through February in 2 consecutive years, might reduce the number of recurrent respiratory infections when compared with placebo (10785).
• Rheumatoid arthritis (RA). It is unclear if oral alpha-linolenic acid is beneficial in patients with RA. Details: Preliminary clinical research shows that taking an alpha-linolenic acid-rich oil (flaxseed oil) for 3 months does not improve symptoms or laboratory parameters of RA when compared with baseline or with a linoleic acid-rich oil (safflower oil) (5898).
• Systemic lupus erythematosus (SLE). Although there is interest in using oral alpha-linolenic acid (ALA) for SLE, there is insufficient reliable information about the clinical effects of ALA for this condition.
• Ulcerative colitis. Although there is interest in using oral alpha-linolenic acid (ALA) for ulcerative colitis, there is insufficient reliable information about the clinical effects of ALA for this condition. More evidence is needed to rate alpha-linolenic acid for these uses.

(Read more about ALPHA-LINOLENIC ACID (ALA))

POSSIBLY EFFECTIVE

• Diabetic neuropathy. Clinical research suggests that oral GLA may improve nerve function and symptoms of diabetic neuropathy in patients with type 1 and type 2 diabetes. Details: Two clinical trials in patients with type 1 or type 2 diabetes and diabetic neuropathy show that taking GLA 360-480 mg daily for 6-12 months improves measures of nerve function and symptoms of neuropathy, including muscle weakness, impaired tendon reflexes, and impaired sensation, when compared with placebo (1984,8926). GLA seems to be more effective in patients with better glucose control when compared with patients with poor glucose control (8926).

POSSIBLY INEFFECTIVE

• Atopic dermatitis (eczema). Most research suggests that oral GLA does not improve the symptoms or severity of atopic dermatitis in children and adults. Details: A meta-analysis of 11 small clinical studies in children and adults with atopic dermatitis shows that taking GLA from borage oil or evening primrose oil does not improve the severity of atopic dermatitis when compared with placebo oils. Adult doses in these studies ranged from 132-720 mg daily for 3-24 weeks. Child doses ranged from 90-480 mg daily for 3-16 weeks (13758). Also, a more recent clinical study in adults with mild-to-moderate atopic dermatitis shows that taking a food product containing GLA 200 mg daily for 12 weeks does not improve skin hydration, itching, or redness when compared with a control (92868). Conversely, one small open-label clinical trial in infants with atopic dermatitis shows that taking GLA 3 grams daily for 4 weeks might reduce redness, itching, and use of antihistamines when compared to baseline (51042). The validity of these findings is limited by a lack of placebo control.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acute respiratory distress syndrome (ARDS). Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of randomized controlled trials evaluating GLA, fish oil, and antioxidants, provided as a specific enteral formula (Oxepa, Abbott Nutrition) or a combination supplement given as a bolus, shows that there is no effect on overall all-cause mortality or ventilator- or ICU-free days when compared with generally isonitrogenous and isocaloric control formulas. A subgroup analysis of lower quality research shows that there may be a modest benefit for patients with a higher risk of mortality (105250). Two more recent meta-analyses have yielded similar results. Although most of the studies included in these meta-analyses investigated the use of Oxepa, some studies investigating other sources of enteral or intravenous fish oil were also included (105248,105249). In one of these analyses, some low- to very low-quality evidence suggests that use of Oxepa modestly reduces mortality at 28 days, as well as ICU length of stay and duration of mechanical ventilation (105248). However, these benefits were not found in the second meta-analysis (105249). It is unclear if GLA, when used alone, is beneficial in patients with ARDS.
• Asthma. Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with asthma shows that taking 10 grams of a medical food emulsion providing GLA 0.75 grams with eicosapentaenoic acid (EPA) 0.5 grams, or 15 grams of a medical food emulsion providing GLA 1.13 grams with EPA 0.75 grams, daily for 4 weeks does not improve self-reported overall symptoms of asthma and bronchodilator use at 2 or 4 weeks when compared with placebo. Another small clinical study shows that taking medical food EFF1009, providing GLA 0.75 grams and EPA 0.5 grams, daily for 4 weeks modestly reduces bronchodilator use and improves quality of life and symptoms such as wheezing when compared to baseline (105251). The validity of this finding is limited by the lack of a comparator group and a high dropout rate.
• Attention deficit-hyperactivity disorder (ADHD). Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in drug-naïve children ages 6 to 12 years with mild to moderate ADHD shows that taking GLA 60 mg in combination with eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) daily for 12 months results in some small beneficial effects on inattentive symptoms when compared with placebo. However, these changes are unlikely to be clinically useful. Also, there was no change in blood levels of fatty acids (111058). The effect of GLA itself is unclear from this study.
• Autism spectrum disorder. Although there has been interest in using oral GLA for autism spectrum disorder, there is insufficient reliable information about the clinical effects of GLA for this purpose.
• Back pain. Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One clinical trial in patients with back pain due to compressive radiculopathy syndrome shows that taking GLA 360 mg and alpha-lipoic acid 600 mg daily for 6 weeks while undergoing rehabilitation therapy reduces pain intensity and improves disability status when compared with rehabilitation therapy alone (20489). It is unclear if these findings are due to GLA, alpha-lipoic acid, or the combination.
• Breast cancer. It is unclear if oral GLA is beneficial in patients with breast cancer. Details: A small clinical study in patients with various stages of endocrine-sensitive breast cancer shows that taking GLA 2.8 grams daily along with tamoxifen for 6 weeks seems to improve the response to tamoxifen when compared with tamoxifen alone (5902).
• Hyperlipidemia. Although there has been interest in using oral GLA for hyperlipidemia, there is insufficient reliable information about the clinical effects of GLA for this purpose.
• Hypertension. Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial in patients with modestly elevated diastolic blood pressure (DBP) shows that taking a combination of GLA 0.12 grams plus eicosapentaenoic acid (EPA) 0.48 grams does not reduce DBP when compared with olive oil (13771). However, another small clinical study in patients with hypertension shows that taking 4 grams of an oil preparation rich in GLA, EPA, and docosahexaenoic acid (DHA) daily for 6 weeks reduces DBP when compared with sunflower seed oil (51022). It is unclear if these findings are due to GLA, other ingredients, or the combination.
• Mastalgia. Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small preliminary clinical trial in patients with mastalgia shows that taking GLA 100 mg daily in combination with vitamin C and vitamin B12 as methylcobalamin for 12 weeks does not improve the proportion of patients with minimal or no pain when compared with taking placebo (111059).
• Menopausal symptoms. Although there has been interest in using oral GLA for menopausal symptoms, there is insufficient reliable information about the clinical effects of GLA for this purpose.
• Pressure ulcers. Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with acute lung injury shows that taking a specific enteral emulsion (Oxepa, Ross Laboratories) providing GLA from borage oil along with fish oil and vitamins A, C and E for 7 days does not improve the healing of existing pressure ulcers when compared with a control enteral formula. Although the number of pressure ulcers in the group given the GLA-containing formula was lower when compared with the control formula, these patients also had fewer pressure ulcers at baseline and no statistical comparison was conducted. The clinical significance of this finding is unclear (105252).
• Psoriasis. Although there has been interest in using oral GLA for psoriasis, there is insufficient reliable information about the clinical effects of GLA for this purpose.
• Rheumatoid arthritis (RA). Although there has been interest in using oral GLA for RA, there is insufficient reliable information about the clinical effects of GLA for this purpose.
• Rosacea. It is unclear if oral GLA is beneficial in patients with rosacea. Details: A small clinical study in adults with rosacea shows that taking GLA (Evoprim) 320 mg daily along with minocycline 50 mg twice daily for 8 weeks improves patient satisfaction and measures of skin hydration and increases the rate of treatment success, defined as an investigator global assessment score of 1 or lower, indicating clear or minimal symptoms, by 2-fold when compared with placebo plus minocycline (107927).
• Scleroderma. It is unclear if oral GLA is beneficial in patients with scleroderma. Details: A small clinical study in patients with scleroderma shows that taking GLA (dose unknown) for 6 months does not reduce symptoms of scleroderma when compared with placebo (1977).
• Ulcerative colitis. Oral GLA has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with ulcerative colitis shows that taking a combination of GLA 1.6 grams, eicosapentaenoic acid (EPA) 270 mg, and docosahexaenoic acid (DHA) 45 mg daily for 12 months does not reduce symptoms when compared with placebo (51013). More evidence is needed to rate GLA for these uses.

(Read more about GAMMA-LINOLENIC ACID (GLA))

POSSIBLY INEFFECTIVE

• Cardiovascular disease (CVD). Most research suggests that increasing dietary intake of omega-6 fatty acids does not reduce the risk of CVD. Details: A meta-analysis including 19 low-quality randomized controlled trials that followed patients for 1-8 years shows that higher intake of omega-6 fatty acids for at least 12 months does not reduce the risk of primary or secondary CVD events, coronary heart disease (CHD) events, stroke, or all-cause or CVD mortality when compared with a lower intake. The intake of omega-6 fatty acids ranged from 0.8% to 20.6% of energy (99973). Population research conducted over about 7.3 years has also found that baseline red blood cell omega-6 fatty acid levels are not associated with CVD events, CHD events, ischemic strokes, CVD deaths, or all-cause mortality (99974), and red blood cell omega-6 fatty acid levels do not differ between people with or without coronary artery disease in patients hospitalized for coronary angiography (96918). However, some research suggests that individual omega-6 fatty acids may have differing effects in the body. One population study has found that increased levels of shorter chain omega-6 fatty acids in red blood cells, including linoleic acid, gamma linolenic acid, and dihomo-gamma linolenic acid, are associated with a reduced risk of CVD mortality. Higher levels of the longer chain omega-6 fatty acids adrenic acid and docosapentaenoic acid are associated with a moderately increased risk of overall mortality in these patients (96918). Higher quality studies are needed to confirm these findings.
• Child development. Most research suggests that supplementing infant formula with arachidonic acid, an omega-6 fatty acid, and docosahexaenoic acid (DHA), an omega-3 fatty acid, does not improve infant or child development. Details: Meta-analyses of clinical research show that inclusion of arachidonic acid in infant formula at levels of up to 0.84% of fatty acids, in addition to DHA, for 2-12 months does not improve visual or neurodevelopmental outcomes in preterm or full-term infants up to 18 months of age (96919,96920). Also, giving infants DHA- and arachidonic acid-supplemented formula during infancy does not appear to improve neurodevelopment by the age of 6 years (92503).
• Hyperlipidemia. Increasing dietary intake of omega-6 fatty acids does not seem to lower plasma cholesterol or triglyceride levels. Details: A meta-analysis of clinical research shows that increasing intake of omega-6 fatty acids, specifically linoleic acid or gamma-linolenic acid, by replacing dietary saturated or monounsaturated fatty acids modestly reduces levels of total cholesterol. However, the clinical significance is unclear. Also, increasing intake of omega-6 fatty acids does not seem to affect levels of high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, or triglycerides (99973).
• Multiple sclerosis (MS). Most research suggests that taking omega-6 fatty acids is not beneficial for MS. Details: A meta-analysis of the available literature shows that taking omega-6 fatty acids, mainly as linoleic acid, does not seem to prevent disease progression in relapsing-remitting MS patients or chronic progressive MS patients at 24 months (107318).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Age-related cognitive decline. It is unclear if increased dietary omega-6 fatty acid intake is beneficial for preventing age-related cognitive decline. Details: Population research has found that the highest blood levels of omega-6 fatty acids during middle age are associated with the best overall cognitive functioning 13 years later when compared with lower intakes (99979). In addition, the highest tertile of omega-6 fatty acid intake in older adults, at least 8.8 mg per kcal daily, is inversely associated with having low cognitive performance. However, the same pattern was observed for the highest tertile of omega-3 fatty acids, and the omega-6 to omega-3 fatty acid ratio in the diet had no overall association with cognitive performance (103308).
• Attention deficit-hyperactivity disorder (ADHD). Oral omega-6 fatty acids have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research shows that taking a combination of omega-3 and omega-6 fatty acids twice daily for 3-6 months does not improve symptoms of ADHD in most children when compared with placebo, although it may improve ADHD symptoms in a subgroup of children with ADHD inattentive subtype plus comorbid neurodevelopmental disorders (65864).
• Blepharitis. It is unclear if oral omega-6 fatty acids are beneficial for blepharitis. Details: One preliminary clinical study in patients with Meibomian gland dysfunction shows that taking a specific product (Medilar, Fidia Oftal Bausch & Lomb Pharmaceuticals), which contains the omega-6 fatty acids linoleic acid 28.5 mg and gamma-linolenic acid 15 mg, once daily for 180 days in combination with eyelid hygiene can improve cloudiness from eye secretions and gland obstruction when compared with baseline (66665). However, the lack of a control group limits the validity of these results. Population research involving postmenopausal adults has also found that moderate dietary intake of omega-6 fatty acids is associated with a reduced risk of developing Meibomian gland dysfunction. However, high intake was not associated with a reduced risk in these patients, and the protective effect of omega-6 fatty acids, if any, in the general population is unclear (99978). Higher quality research is needed to confirm these results.
• Cancer. It is unclear if increased dietary intake of omega-6 fatty acids is beneficial for cancer prevention. Details: In a meta-analysis of clinical research, increasing intake of dietary omega-6 fatty acids does not seem to reduce cancer risk or mortality. However, the included research is of low quality (107005). Also, a meta-analysis of population research has found that dietary intake of omega-6 fatty acids is not associated with cancer risk. However, high blood levels of omega-6 fatty acids were associated with an 8% reduced risk of cancer when compared to low blood levels, with breast cancer carrying the strongest association. Each 5% increase in blood levels of omega-6 fatty acids was associated with a 2% decreased cancer risk (107006). These results should be interpreted with caution, since factors other than omega-6 fatty acid intake, such as alcohol intake or overall diet, may affect blood levels of omega-6 fatty acids (100516).
• Developmental coordination disorder (DCD). Oral omega-6 fatty acids have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research shows that taking a combination of omega-6 and omega-3 fatty acids for 3 months can improve reading, spelling, and behavior, but not motor skills, when compared with placebo in children with DCD (13748).
• Diabetes. It is unclear if higher dietary or supplemental intake of omega-6 fatty acids is associated with a reduced risk of diabetes. Details: Population research has found that the highest blood levels of the omega-6 fatty acid linoleic acid are associated with a 43% reduced risk of developing diabetes over a period of 5-42 years when compared with the lowest blood levels. Blood levels of another omega-6 fatty acid, arachidonic acid, do not seem to be linked to diabetes risk (96914). These results should be interpreted with caution, since factors other than omega-6 fatty acid intake, such as alcohol intake or overall diet, may affect blood levels of omega-6 fatty acids (100516). In addition, a meta-analysis of low-quality clinical research does not support any benefit of omega-6 fatty acids in the prevention or treatment of type 2 diabetes (101504).
• Diarrhea. It is unclear if formula supplemented with arachidonic acid is beneficial for diarrhea prevention in infancy. Details: Preliminary clinical research shows that infant formula supplemented with arachidonic acid 34 mg/100 kcal and docosahexaenoic (DHA) acid, an omega-3 fatty acid, 17 mg/100 kcal (Enfamil Premium 1 and Enfamil Premium 2, Mead Johnson Nutrition) can reduce the incidence of diarrhea in the first year of life when compared with non-supplemented infant formula (92505).
• Dry eye. It is unclear if dietary intake of omega-6 fatty acids is beneficial for dry eye prevention. Details: Population research has found that higher intake of dietary omega-6 fatty acids is not associated with a reduced risk of dry eye after menopause (99978).
• Hypertension. It is unclear if dietary intake of omega-6 fatty acids is beneficial for blood pressure reduction. Details: Population research has found that higher dietary intake of omega-6 fatty acids, especially linoleic acid, is inversely associated with the odds of hypertension in non-diabetic individuals. However, in patients with diabetes, higher intake of omega-6 fatty acids is associated with an increased odds of hypertension (99975).
• Nonalcoholic fatty liver disease (NAFLD). It is unclear if dietary intake of omega-6 fatty acids is beneficial for NAFLD prevention. Details: Cross-sectional population research is mixed with respect to dietary intake of omega-6 fatty acids in patients with NAFLD when compared with healthy controls. One large cross-sectional study based on data from the National Health and Nutrition Examination Survey (NHANES) between 2007-2014 has found that consuming omega-6 fatty acids at a dose of at least 250 mg/kg daily is associated with an 82% reduced risk of having NAFLD when compared with consuming less than 121.3 mg/kg daily (107002).
• Obesity. It is unclear if oral omega-6 fatty acids are beneficial for reducing cholesterol or triglyceride levels in adults with obesity. Details: In individuals with abdominal obesity, a small clinical trial shows that taking linoleic acid 15 grams (females) or 20 grams (males) (Pharmatech AS) daily for 7 weeks from safflower oil has modest beneficial effects on levels of low-density lipoprotein (LDL)-, high-density lipoprotein (HDL)-, and total cholesterol when compared with baseline or taking fish oil. However, there was no effect on triglyceride levels (107003).
• Photoreactive keratectomy. Oral omega-6 fatty acids have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research in patients who have undergone photoreactive keratectomy shows that taking a tablet containing the omega-6 fatty acids linoleic acid and gamma-linolenic acid, as well as beta-carotene, B vitamins, and trace minerals, daily for 30 days can improve tear production and eye healing when compared with a control group (66679).
• Respiratory tract infections. It is unclear if supplementing infant formula with arachidonic acid is beneficial for preventing respiratory tract infections. Details: Preliminary clinical research shows that infant formula supplemented with arachidonic acid 34 mg/100 kcal and docosahexaenoic acid (an omega-3 fatty acid) 17 mg/100 kcal (Enfamil Premium 1 and Enfamil Premium 2, Mead Johnson Nutrition) can reduce the incidence of respiratory illness in the first year of life when compared with non-supplemented infant formula (92505). More evidence is needed to rate omega-6 fatty acids for these uses.

(Read more about OMEGA-6 FATTY ACIDS)

LIKELY EFFECTIVE

• Cystic fibrosis. Long-term nebulized hypertonic sodium chloride improves lung function and reduces pulmonary exacerbations in patients with cystic fibrosis. Details: Meta-analyses of clinical research in adults with cystic fibrosis show that, when taken along with a bronchodilator and other standard therapies, nebulized hypertonic sodium chloride in concentrations of 3% to 7%, up to 10 mL twice daily for 4 weeks, increases forced expiratory volume at one second (FEV1) when compared with isotonic saline (sodium chloride 0.9%) (26230,26230). This benefit was not seen at 48 weeks. Other clinical research in adults with cystic fibrosis shows that inhaling sodium chloride 7%, 4 mL twice daily for 48 weeks, does not improve FEV1 when compared with isotonic saline. However, chronic treatment with hypertonic saline does reduce the number of pulmonary exacerbations and increase the number of patients without pulmonary exacerbations when compared with isotonic saline (29402). It is not clear if this benefit occurs in children with cystic fibrosis. The Pulmonary Clinical Practice Guidelines Committee of the Cystic Fibrosis Foundation recommends that individuals with cystic fibrosis aged 6 years or older use nebulized hypertonic saline long-term to improve lung function, reduce the number of exacerbations, and improve quality of life (29403).

POSSIBLY EFFECTIVE

• Amphotericin B nephrotoxicity. Oral sodium chloride seems to prevent nephrotoxicity associated with use of amphotericin B. Details: Clinical research shows that administering oral or intravenous sodium chloride 150 mEq daily during treatment with amphotericin B can attenuate the rise in serum creatinine levels and preserve renal function when compared to treatment with amphotericin B alone (26226).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Bipolar disorder. It is unclear if oral sodium is beneficial in preventing lithium level fluctuations in patients with bipolar disorder. Details: A moderate-sized open-label clinical study in adults with type I bipolar disorder receiving lithium carbonate shows that taking sodium chloride 1 gram daily for 12 weeks along with dietary salt restriction of 1 gram daily reduces the percentage of patients with lithium level fluctuations above 0.8 mEq/L, but does not significantly affect serum sodium, potassium, aldosterone, or creatinine levels when compared with controls who were not salt restricted, but were advised not to consume additional salt at the table (112909). However, the interpretation of these findings is limited by missing data in both groups.
• Canker sores. Although there is interest in using topical sodium chloride for canker sores, there is insufficient reliable information about the clinical effects of sodium chloride for this condition.
• Congestive heart failure. It is unclear if oral sodium is beneficial in patients with acute decompensated heart failure requiring decongestive therapy with diuretics. Details: A moderate-sized clinical study in adults hospitalized with acute decompensated heart failure requiring high-dose intravenous furosemide shows that taking sodium chloride 2 grams three times daily for up to 96 hours does not affect patient weight or serum creatinine levels when compared with placebo (112911). However, the clinical relevance of this study is unclear and it may have been inadequately powered to detect a difference between groups.
• Conjunctivitis. Although there is interest in using ophthalmic sodium chloride for conjunctivitis, there is insufficient reliable information about the clinical effects of sodium chloride for this condition.
• Hyponatremia. Although there is interest in using oral sodium chloride for hyponatremia, there is insufficient reliable information about the clinical effects of oral sodium chloride for this condition.
• Pharyngitis. Although there is interest in using topical sodium chloride for pharyngitis, there is insufficient reliable information about the clinical effects of sodium chloride for this condition.
• Prematurity. It is unclear if oral sodium is beneficial for premature infants. Details: Preliminary clinical research in infants born at less than 32 weeks' gestation shows that adding sodium 4 mEq/kg daily to enteral feedings, starting from the 7th day after birth and continuing through the 35th day, reduces the risk of developing hyponatremia and improves weight gain when compared with adding water (98180). A small, open-label clinical study in newborns less than 35 weeks gestation shows that high sodium intake, defined as an average of 0.25% sodium in maintenance fluids, for 48 hours on day 2 and 3 after birth results in less weight loss within the first 72 hours of life when compared with control, but does not improve mortality, length of hospital stay, or complications from prematurity (112908). However, interpretation of these findings is limited by varied concentrations of sodium as an intervention. More evidence is needed to rate sodium for these uses.

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LIKELY SAFE ...when used orally in amounts typically found in foods (7141,7142,7144). There is insufficient reliable information available about the safety of alpha-linolenic acid when used in larger, medicinal amounts.

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts typically found in foods (7141,7142,7145). There is insufficient reliable information available about the safety of alpha-linolenic acid during pregnancy and lactation when used in larger, medicinal amounts; avoid using.

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POSSIBLY SAFE ...when used orally and appropriately. GLA appears to be safe when taken in oral doses of up to 2.8 grams daily for up to a year (1983,7701,7702,8926,107927).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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LIKELY SAFE ...when used orally in amounts found in foods. Dietary intake in amounts of 5% to 10% of daily calories are appropriate according to the Dietary Reference Intake (DRI) Acceptable Macronutrient Distribution Range (AMDR) (23723). There is insufficient reliable information available about the safety of omega-6 fatty acids when used orally in medicinal amounts.

CHILDREN: LIKELY SAFE
when consumed by children over the age of 12 months as part of the diet in amounts between 5% to 10% of daily calories according to the Dietary Reference Intake (DRI) Acceptable Macronutrient Distribution Range (AMDR) (23723).

PREGNANCY AND LACTATION: LIKELY SAFE
when consumed as part of the diet in amounts between 5% and 10% of daily calories according to the Dietary Reference Intake (DRI) Acceptable Macronutrient Distribution Range (AMDR) (23723).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when high amounts of omega-6 fatty acids are consumed in the diet. Population research suggests that the highest maternal intakes of omega-6 fatty acids (15.2-47.6 grams or 137-428 kcal daily) during pregnancy is associated with a 2.4-times greater odds of giving birth to an infant below the 10th percentile for birth weight when compared with the lowest maternal intakes (0.4-5.7 grams daily) (96913). In addition, population research in women with a history of atopy suggests that the highest blood levels of omega-6 fatty acids during the second trimester is associated with an increased odds of having a child develop atopic dermatitis by age 4-6 years when compared with the lowest intakes (103309). There is insufficient reliable information available about supplemental omega-6 fatty acids; avoid using.

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LIKELY SAFE ...when used orally and appropriately. Sodium is safe in amounts that do not exceed the Chronic Disease Risk Reduction (CDRR) intake level of 2.3 grams daily (100310). Higher doses can be safely used therapeutically with appropriate medical monitoring (26226,26227).

POSSIBLY UNSAFE ...when used orally in high doses. Tell patients to avoid exceeding the CDRR intake level of 2.3 grams daily (100310). Higher intake can cause hypertension and increase the risk of cardiovascular disease (26229,98176,98177,98178,98181,98183,98184,100310,109395,109396,109398,109399). There is insufficient reliable information available about the safety of sodium when used topically.

CHILDREN: LIKELY SAFE
when used orally and appropriately (26229,100310). Sodium is safe in amounts that do not exceed the CDRR intake level of 1.2 grams daily for children 1 to 3 years, 1.5 grams daily for children 4 to 8 years, 1.8 grams daily for children 9 to 13 years, and 2.3 grams daily for adolescents (100310).

CHILDREN: POSSIBLY UNSAFE
when used orally in high doses. Tell patients to avoid prolonged use of doses exceeding the CDRR intake level of 1.2 grams daily for children 1 to 3 years, 1.5 grams daily for children 4 to 8 years, 1.8 grams daily for children 9 to 13 years, and 2.3 grams daily for adolescents (100310). Higher intake can cause hypertension (26229).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately. Sodium is safe in amounts that do not exceed the CDRR intake level of 2.3 grams daily (100310).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally in higher doses. Higher intake can cause hypertension (100310). Also, both the highest and the lowest pre-pregnancy sodium quintile intakes are associated with an increased risk of hypertensive disorders of pregnancy, including gestational hypertension and pre-eclampsia, and the delivery of small for gestational age (SGA) infants when compared to the middle intake quintile (106264).

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, GLA might increase the risk of bleeding when taken with anticoagulant or antiplatelet rugs.  Details Animal and human research suggests that GLA reduces platelet aggregation (1979).

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ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = A Theoretically, a high intake of dietary sodium might reduce the effectiveness of antihypertensive drugs.  Details High intake of dietary sodium can increase systolic and diastolic blood pressure (26222). Also, high intake of sodium may necessitate increased use of antihypertensive medications to achieve blood pressure control in some patients, such as those with chronic kidney disease (26223).

CORTICOSTEROIDS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Concomitant use of mineralocorticoids and some glucocorticoids with sodium supplements might increase the risk of hypernatremia.  Details Mineralocorticoids and some glucocorticoids (corticosteroids) cause sodium retention. This effect is dose-related and depends on mineralocorticoid potency. It is most common with hydrocortisone, cortisone, and fludrocortisone, followed by prednisone and prednisolone (4425).

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Altering dietary intake of sodium might alter the levels and clinical effects of lithium.  Details High sodium intake can reduce plasma concentrations of lithium by increasing lithium excretion (26225). Reducing sodium intake can significantly increase plasma concentrations of lithium and cause lithium toxicity in patients being treated with lithium carbonate (26224,26225). Stabilizing sodium intake is shown to reduce the percentage of patients with lithium level fluctuations above 0.8 mEq/L (112909). Patients taking lithium should avoid significant alterations in their dietary intake of sodium.

SODIUM-CONTAINING DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Concomitant use of sodium-containing drugs with additional sodium from dietary or supplemental sources may increase the risk of hypernatremia and long-term sodium-related complications.  Details The Chronic Disease Risk Reduction (CDRR) intake level of 2.3 grams of sodium daily indicates the intake at which it is believed that chronic disease risk increases for the apparently healthy population (100310). Some medications contain high quantities of sodium. When used in conjunction with sodium supplements or high-sodium diets, the CDRR may be exceeded. Additionally, concomitant use may increase the risk for hypernatremia; this risk is highest in the elderly and people with other risk factors for electrolyte disturbances.

TOLVAPTAN (Samsca) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = C Theoretically, concomitant use of tolvaptan with sodium might increase the risk of hypernatremia.  Details Tolvaptan is a vasopressin receptor 2 antagonist that is used to increase sodium levels in patients with hyponatremia (29406). Patients taking tolvaptan should use caution with the use of sodium salts such as sodium chloride.

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General ...Orally, alpha-linolenic acid from dietary sources is well tolerated when used in the diet as a replacement for other sources of fat, such as saturated fats.
Serious Adverse Effects (Rare):
Orally: There is some concern that high dietary intake of alpha-linolenic acid might increase the risk for prostate cancer, although research is conflicting.

Oncologic ...Epidemiologic research suggests that high dietary intake of alpha-linolenic acid might increase risk for prostate cancer (1337,2558,7823,7147,12978). Other research suggests high intake or serum levels of alpha-linolenic acid does not increase the overall risk of prostate cancer (12961,15736); however, it might increase the risk of advanced prostate cancer (12961). Association with prostate cancer appears to depend on the sources of alpha-linolenic acid. Dairy and meat sources has been positively associated with prostate cancer, whereas plant sources, such as flaxseed, don't seem to affect prostate cancer risk (12909). According to a clinical trial, intake of alpha-linolenic acid does not appear to increase levels of prostate specific antigen (PSA) (91402). Also, longer-chain omega-3 fatty acids in fish oils are associated with a decreased risk of total and advanced prostate cancer (12961).

Other ...Alpha-linolenic acid is a type of fat, containing 9 kilocalories/gram, and may result in weight gain if consumed in excess. Patients should be advised that it's best to substitute alpha-linolenic acid in the diet for other sources of fat, such as saturated fats.

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General ...Orally, GLA seems to be well tolerated.
Most Common Adverse Effects:
Orally: Mild gastrointestinal adverse effects, including belching, bloating, diarrhea, dyspepsia, flatulence, nausea, and vomiting.

Gastrointestinal ...Orally, GLA may cause mild gastrointestinal effects such as dyspepsia, nausea, bloating, vomiting, soft stools, diarrhea, flatulence, and belching (7701,7702,8926,107927).

Hematologic ...Orally, GLA might prolong bleeding time (1979).

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General ...Orally, consuming omega-6 fatty acids in amounts found in foods is well tolerated.

Cardiovascular ...Dietary intake of the omega-6 fatty acid linoleic acid in amounts of 5% to 10% of daily calories is appropriate according to the Dietary Reference Intake (DRI) Acceptable Macronutrient Distribution Range (AMDR) (23723). However, higher intake levels, especially when compared with omega-3 fatty acid intake, might be detrimental. For example, a higher ratio of dietary omega-6 to omega-3 fatty acids is thought to increase the risk of cardiovascular disease compared to a lower ratio (66678). However, the American Heart Association Nutrition Subcommittee of the Council on Nutrition, Physical Activity, and Metabolism, the Council on Cardiovascular Nursing, and the Council on Epidemiology and Prevention, suggest that reduction of omega-6 fatty acids in the diet is unlikely to be beneficial for the cardiovascular system if replaced with saturated or trans-fatty acids (66692). Population research has found that higher intake of omega-6 fatty acids might be associated with hypertension and increased levels of plasma homocysteine, a risk factor for cardiovascular disease and atherosclerosis (65498,66640,66642).

Musculoskeletal ...In epidemiological research, increased intake of omega-6 fatty acids was associated with elevated risk of fracture in the elderly (66662).

Neurologic/CNS ...In epidemiological research, an increased dietary ratio of omega-6 fatty acids to omega-3 fatty acids has been associated with an elevated risk of having a sleep disorder (107001).

Oncologic ...Some population research has found that high omega-6 fatty acid intake or blood levels are associated with an increased risk for cancer, including breast cancer and prostate cancer (3508,7824,66660,66664,66729).

Psychiatric ...In epidemiological research, adolescents with attention-deficit hyperactivity disorder (ADHD) had higher levels of omega-6 and lower levels of omega-3 fatty acids in red blood cells (48200). The role of omega-6 fatty acids in ADHD is unclear; it is possible that the low levels of omega-3 fatty acids and essential fatty acids in general may be playing a role. Also, higher levels of some omega-6 fatty acids in the body are associated with greater depressive symptomology and neuroticism (65815,66659). Higher concentrations of some omega-6 fatty acids in red blood cells of patients with schizophrenia are correlated with positive schizotypal trait measures in healthy adults (66635). This may be related to increased intake of omega-6 fatty acids in the diet of patients with schizophrenia (96916).

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General ...Orally, sodium is well tolerated when used in moderation at intakes up to the Chronic Disease Risk Reduction (CDRR) intake level. Topically, a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: Worsened cardiovascular disease, hypertension, kidney disease.

Cardiovascular ...Orally, intake of sodium above the CDRR intake level can exacerbate hypertension and hypertension-related cardiovascular disease (CVD) (26229,98176,100310,106263). A meta-analysis of observational research has found a linear association between increased sodium intake and increased hypertension risk (109398). Observational research has also found an association between increased sodium salt intake and increased risk of CVD, mortality, and cardiovascular mortality (98177,98178,98181,98183,98184,109395,109396,109399). However, the existing research is unable to confirm a causal relationship between sodium intake and increased cardiovascular morbidity and mortality; high-quality, prospective research is needed to clarify this relationship (100312). As there is no known benefit with increased salt intake that would outweigh the potential increased risk of CVD, advise patients to limit salt intake to no more than the CDRR intake level (100310).
A reduction in sodium intake can lower systolic blood pressure by a small amount in most individuals, and diastolic blood pressure in patients with hypertension (100310,100311,106261). However, post hoc analysis of a small crossover clinical study in White patients suggests that 24-hour blood pressure variability is not affected by high-salt intake compared with low-salt intake (112910). Additionally, the available research is insufficient to confirm that a further reduction in sodium intake below the CDRR intake level will lower the risk for chronic disease (100310,100311). A meta-analysis of clinical research shows that reducing sodium intake increases levels of total cholesterol and triglycerides, but not low-density lipoprotein (LDL) cholesterol, by a small amount (106261).
It is unclear whether there are safety concerns when sodium is consumed in amounts lower than the adequate intake (AI) levels. Some observational research has found that the lowest levels of sodium intake might be associated with increased risk of death and cardiovascular events (98181,98183). However, this finding has been criticized because some of the studies used inaccurate measures of sodium intake, such as the Kawasaki formula (98177,98178,101259). Some observational research has found that sodium intake based on a single 24-hour urinary measurement is inversely correlated with all-cause mortality (106260). The National Academies Consensus Study Report states that there is insufficient evidence from observational studies to conclude that there are harmful effects from low sodium intake (100310).

Endocrine ...Orally, a meta-analysis of observational research has found that higher sodium intake is associated with an average increase in body mass index (BMI) of 1. 24 kg/m2 and an approximate 5 cm increase in waist circumference (98182). It has been hypothesized that the increase in BMI is related to an increased thirst, resulting in an increased intake of sugary beverages and/or consumption of foods that are high in salt and also high in fat and energy (98182). One large observational study has found that the highest sodium intake is not associated with overweight or obesity when compared to the lowest intake in adolescents aged 12-19 years when intake of energy and sugar-sweetened beverages are considered (106265). However, in children aged 6-11 years, usual sodium intake is positively associated with increased weight and central obesity independently of the intake of energy and/or sugar-sweetened beverages (106265).

Gastrointestinal ...In one case report, severe gastritis and a deep antral ulcer occurred in a patient who consumed 16 grams of sodium chloride in one sitting (25759). Chronic use of high to moderately high amounts of sodium chloride has been associated with an increased risk of gastric cancer (29405).

Musculoskeletal ...Observational research has found that low sodium levels can increase the risk for osteoporosis. One study has found that low plasma sodium levels are associated with an increased risk for osteoporosis. Low levels, which are typically caused by certain disease states or chronic medications, are associated with a more than 2-fold increased odds for osteoporosis and bone fractures (101260).
Conversely, in healthy males on forced bed rest, a high intake of sodium chloride (7.7 mEq/kg daily) seems to exacerbate disuse-induced bone and muscle loss (25760,25761).

Oncologic ...Population research has found that high or moderately high intake of sodium chloride is associated with an increased risk of gastric cancer when compared with low sodium chloride intake (29405). Other population research in patients with gastric cancer has found that a high intake of sodium is associated with an approximate 65% increased risk of gastric cancer mortality when compared with a low intake. When zinc intake is taken into consideration, the increased risk of mortality only occurred in those with low zinc intake, but the risk was increased to approximately 2-fold in this sub-population (109400).

Pulmonary/Respiratory ...In patients with hypertension, population research has found that sodium excretion is modestly and positively associated with having moderate or severe obstructive sleep apnea. This association was not found in normotensive patients (106262).

Renal ...Increased sodium intake has been associated with impaired kidney function in healthy adults. This effect seems to be independent of blood pressure. Observational research has found that a high salt intake over approximately 5 years is associated with a 29% increased risk of developing impaired kidney function when compared with a lower salt intake. In this study, high salt intake was about 2-fold higher than low salt intake (101261).

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