Dietary Supplements: A Position Paper for Jewish Hospital Cholesterol Center patients

Charles J. Glueck MD, Medical Director

General Recommendations:

With the probable exception of supplemental vitamin D, the average American does not need, and SHOULD NOT TAKE vitamin, mineral, or protein-amino acid supplements. In particular, protein-amino acid supplements, when taken in conjunction with high level (dehydrating) aerobic exercise, can injure the kidney through excessive solute load.
In general, potential toxicity and or side-effects from excessive use of dietary supplements and potential toxic contaminants in some of these products are more concerning than nutritional deficiency in the great majority of our patients, (i.e. health conscious, informed, individuals).
The American Dietetic Association1 (ADA) has concluded that the best nutritional strategy for optimizing health and reducing the risk of chronic disease is to choose wisely from a wide variety of nutritious foods. A consensus report from the NIH2 concluded that the present evidence is insufficient to recommend either for or against the use of multivitamin and mineral supplements to prevent chronic disease.
After reviewing medical and scientific information, we have categorized dietary supplements into two categories: 1) Supplements of Potential Value; and 2) Supplements of Limited Benefit and/or Potentially Harmful.
A person’s nutritional status cannot be easily ascertained through screening of vitamins and minerals in a blood test.

NOTE: Many of the vitamins and minerals discussed below are required in some amount for important body functions. Dietary supplementation with one or more of these vitamins and minerals, including some of those listed as “Not Recommended”, is indicated for the treatment of certain patients with specific medical diagnoses.

Our process for creating these lists did not take individual patient medical and health histories into consideration. Therefore, we advise our patients to ask their personal health care providers and dieticians for advice before beginning new supplements or discontinuing current supplements.

Supplements of Potential Value:

B Vitamins: There is a definite role for B vitamin supplementation (B12, Folic Acid, B6) in subjects with elevated homocysteine and/or methylmalonic acid levels, which have been associated with risk of clotting (thrombosis). Vitamin B 12 malabsorption, if unrecognized, can lead to pernicious anemia, peripheral neuropathy, and dementia. Measurement of methylmalonic acid along with homocysteine in the blood is probably the best and most sensitive way to diagnose vitamin B12 malabsorption, which can be corrected by B12 injections or by a nasal inhaler for B12.
Vitamin D: Vitamin D deficiency and associated health effects are being recognized much more frequently than previously, particularly in heavily pigmented ethnic groups. Serum 25-OH Vitamin D levels are easily measured and widely available. In our experience,3 70% or more of subjects have clinically significant vitamin D deficiency, and this is often associated with myalgia (muscle pain) in subjects concurrently taking statin medications. Supplementation may resolve the muscle pain (myalgias) experienced by some patients who are Vitamin D deficient and are taking statin drugs (e.g. Lipitor, Pravachol, Mevacor, Lescol, Zocor, Crestor). It is important to maintain serum 25 OH vitamin D levels >32 ng/ml, particularly if taking a statin medication.3
Calcium: Calcium supplementation has been recommended for women: e.g. 800 to 1200 mg/day prior to menopause; 1500 mg/day after menopause. The literature is not as clear on the advantages of supplemental calcium for men.
Dietary Approaches to Increase HDL Cholesterol: Numerous dietary products have been advocated for increasing HDL cholesterol levels. Of these, only omega-3-rich fish oil supplements, optimally in the form of prescription Lovaza 1-2 g per day, are of proven benefit. However, cardiovascular exercise ≥ 3 sessions per week, ≥45 minutes per session, avoidance of smoking, and optimal weight control have maximal effects on HDL cholesterol levels, at levels of magnitude ABOVE any nutritional changes.
Saw Palmetto: One large study with over 1000 patients compared Saw Palmetto 320 mg to Finasteride 5mg and found them to be equally effective. The weight of the overall available scientific evidence favors the effectiveness of saw palmetto over placebo in reducing symptoms of benign prostatic hypertrophy (BPH). Very few side effects, none serious, have been associated with typical daily doses of saw palmetto (160 to 320 mg/d). Other products containing beta sitosterols have enjoyed widespread use in Europe for a number of years, although the scientific evidence is less compelling. However, the long term safety of phytoestrogens (including Saw Palmetto) remains to be proven, and until such data are available, we would not favor Saw Palmetto over Finasteride.
Chondroitin Sulfate/ Glucosamine: The NIH conducted a large double-blinded trial over a 6 month study period, involving nearly 1,600 participants 40 years or older with symptomatic osteoarthritis of the knee and Xray changes. This study found no effectiveness of chondroitin sulfate, glucosamine, or combinations of the two overall for treating symptoms of knee osteoarthritis when compared to placebo. There was evidence of statistically significant improvement in a subgroup with moderate to severe disease. A subsequent study looked at Xray changes in participants who continued to take chondroitin sulfate &/or glucosamine for an additional 18 months. There was no evidence of Xray improvement in subjects using these supplements.

Clinically, many patients report symptomatic improvement taking these supplements. Side effects and adverse effects appear to be rare and mild

Supplements of Limited Benefit and/or Potentially Harmful:

Multiple Vitamin & Mineral Supplements: Dietary supplementation with age & gender specific combinations of vitamins, minerals, and antioxidants are of no recognized value for otherwise healthy men and women who eat a healthy diet. Some components may increase some health risks and some may interfere with the beneficial effects of prescription medications. With exceptions of certain chronic diseases, multiple vitamin and mineral supplements should not be taken. In particular, extra iron and copper are pro-oxidants, and oxidize LDL cholesterol to oxidized LDL cholesterol, a much more atherogenic compound. Zinc depresses the good HDL cholesterol.
Beta-Carotene: Two studies looking at possible decreased cancer incidence from Beta-Carotene supplementation cited by the NIH2, demonstrated an increase in lung (one study) and thyroid and bladder (one study) cancer incidence and deaths. There was no evidence of effectiveness in preventing other cancers. Beta Carotene should not be taken as a dietary supplement.
Vitamin A: No studies have documented benefits from Vitamin A supplementation used alone. Lung cancer risk has been found to be elevated when Vitamin A was used in combination with beta-carotene.
Vitamin E: Studies of the benefits and risks of Vitamin E supplementation have led to conflicting results. One large study of women (Women’s Health Study (WHS) showed decreased cardiovascular deaths, but with no change in the incidence of cardiovascular events. There was no increased risk of hemorrhage in women taking Vitamin E supplements in this study. Another study in male smokers showed a decreased incidence of prostate cancer, and a decreased incidence of angina (heart pain) and a stroke caused by blood clots (thrombotic strokes). However, there was a trend for increased risk of bleeding in and around the brain (subarachnoid hemorrhage and hemorrhagic stroke). The potential benefits of Vitamin E supplementation do not clearly outweigh the potential risks.
Vitamin B6: The value of Vitamin B6 supplementation for treating a number of medical conditions (carpal tunnel syndrome, premenstrual syndrome, improving cognitive function, etc.) has not been demonstrated in controlled studies. Ironically, excess Vitamin B 6 supplementation has been identified as a cause for peripheral neuropathy when given as treatment for carpal tunnel syndrome. Overall, Vitamin B 6 should not be taken as a supplement, and if taken as approach to lower homocysteine, should be taken along with 5 mg folic acid, 100 mg B6, and 2000 mcg of B12. Recent studies have raised concerns that folic acid supplementation > 1 mg/day might be associated with increased cancer risk, although an equal number of studies have shown reduced cancer event rates.
Vitamin C: To date, studies have not shown that Vitamin C supplements protect against common colds, upper respiratory infection, or pneumonia. Vitamin C has been shown to increase the levels of high sensitivity C reactive protein, a marker of arterial inflammation.
Calcium and Fiber: Calcium and fiber in combination have been shown to have little effect on LDL cholesterol levels; the combination may decrease LDL levels by a few percent points, at best.
Metals: There is concern about routine use (e.g. not prescribed for specific deficiency) of iron, copper and zinc supplements. Iron and copper appear to oxidize LDL cholesterol; oxidized LDL is even more harmful than non-oxidized LDL cholesterol. Zinc decreases HDL cholesterol levels. There is no convincing evidence that chromium has significant benefit for diabetics as claimed, and chromium piccolinate is not absorbed through the stomach.
Dietary Approaches to Increase HDL Cholesterol: Over-the-counter omega-3-rich fish oils may be contaminated with mercury. Prescription omega-3 rich fish oils (Lovaza) are free of mercury contamination, and lower triglyceride and HDL, but should be used as a medication to treat low HDL levels and not as a dietary supplement. Flax seed oil and alfalfa seeds are relatively poor sources of omega-3 fatty acids and some alfalfa seed supplements have been contaminated with fungicides.
LDL Cholesterol-Lowering Over-the-Counter Products:
1. Red rice yeast: Contains compactin which produces liver tumors and is hepatotoxic in several animal species. We recommend it NOT BE TAKEN.
2. Gum acacia extracts: Adversely affects bowel habits and is ineffective in lowering serum LDL cholesterol.
3. Plant Sterol (Phytosterol) Enriched Products: Phytosterol-enriched milk, margarines, and spreads have minimal effect on lowering LDL cholesterol (< 2% beyond diet); are expensive; and for 11% of the population who hyperabsorb sterols, these products may increase the risk of atherosclerosis.
Fat Soluble Vitamins: Conventional diets include more than enough fat soluble vitamins, with the exception of Vitamin D for some people. Excess Vitamin A and Vitamin E may reduce the cardio-protective effects of lowering LDL levels, and are associated with increased risk of lung cancer and hemorrhagic stroke, respectively. In other words, lowering LDL levels may not convey the same reduction in risk of coronary artery occlusive disease in folks taking Vitamins A and/or E as is afforded by reducing LDL levels in the absence of these vitamin supplements.
Protein Drinks: Powdered and liquid protein drinks have been promoted to improve muscle function after heavy exercise and weight lifting. There is no scientific evidence to back up this claim. In addition, these drinks provide an unhealthy solute load for the kidneys, particularly during periods of post-exercise dehydration, which can reduce kidney function.
Beverage Alcohol: Although approximately 4 oz of red wine per week marginally lowers mortality from heart attack, IT INCREASES ALL CAUSE MORTALITY. Hence, we do NOT recommend patients ingest beverage alcohol daily with a goal of reducing heart attack risk. The lowest all cause mortality is seen in teetotalers.
Herbal Products: The benefits of herbal products appear to be marginal at best. Specifically, herbal products have not been shown to be effective for any of the following: depression, weight reduction, stimulation of sexual potency, or promoting sleep. Serious and at times irreversible toxicity from contaminants in many of these products has been well-documented.

Summary:

People who exercise regularly and maintain a healthy, nutritious diet probably do not require supplements of any kind, other than a B-Vitamin combination in those with elevated MMA or homocysteine levels, Vitamin D in those shown to be deficient, and calcium for women.
Omega 3-fatty acid, preferably in the form of Lovaza, may increase HDL cholesterol levels and substantially lower triglyceride levels in some patients.
Some individuals have specific health conditions that require treatment with other dietary supplements, based on careful diagnosis and targeted therapy.
There is no evidence that exercising vigorously causes any significant vitamin or mineral deficiency and there is no support for recommending supplemental proteins, vitamins, and minerals in very physically active individuals.
Combination multivitamin, mineral and anti-oxidant products are not likely beneficial for individuals who lead a healthy life-style and may be harmful for some. Whereas anti-oxidants have some benefit in animal models, they have no significant benefit in humans.
Fiber and calcium have minimal effect on LDL levels.
To date there is no strong medical evidence supporting the use of popular herbal products for any specific medical indication.

References:

Position of the American Dietetic Association: Fortification and Nutritional Supplements. J Amer Dietetic Assoc 2005;105:1300-1311.
NIH State-of-the-Science Conference Statement of Multivitamin/Mineral Supplements and Chronic Disease Prevention. NIH Consensus and State-of-the-Science Statements 2006; 23(2):1-30.
Ahmed W, Khan N, Glueck CJ, et al. Low serum 25 (OH) vitamin D levels (<32 ng/mL) are associated with reversible myositis-myalgia in statin-treated patients. Transl Res. Jan 2009;153(1):11-16.