Vitamin and Mineral Supplementation Improves Micronutrient Status in Older Adults

Completed · Not applicable · Has a placebo group

Conditions studied: Nutrient Deficiency

In brief

Nutrient intake through diet and nutritional supplements are critical determinants of plasma nutrient status. In addition, untoward drug-nutrient can contribute to nutritional inadequacy. Among medications used by the elderly in the US, diuretics, metformin, and proton pump inhibitors (PPIs) are ranked among the most commonly prescribed. Use of these medications is variously associated with inadequate status of many micronutrients, e.g., vitamins B1, B9 (folate), B12, C, and thiamine and the minerals calcium, iron, potassium, magnesium, and zinc. While diets rich in whole grains, fruits, and vegetables can help decrease the risk for micronutrient inadequacy in older adults using one or more of these drugs, supplementation may prove more effective to restoring and/or enhancing their nutrient status. When compared to a placebo, investigators hypothesize that a multivitamin-multi-mineral (MVM) supplement will improve nutritional status in older adults at increased risk of micronutrient inadequacy induced by drugs commonly used by this population, specifically diuretics, metformin, and PPIs. Investigators also hypothesize that MVM supplementation will beneficially modify selected biomarkers or biochemical pathways of cellular function/health. To test these hypotheses, investigators will conduct a randomized clinical trial by pursuing the following specific aims: 1) To determine the extent by which MVM supplementation (compared to placebo) will increase the plasma status of vitamins B12, C, D, folic acid, and thiamine and the minerals iron, magnesium, potassium, and zinc; 2) To quantify indices of 'metabolic health' including one or more of the following biomarkers: glutathione (GSH)/glutathione disulfide (GSSG) ratio, ubiquinol/ubiquinone, malondialdehyde (MDA), asymmetric dimethyl arginine (ADMA), selected cytokines and chemokines, homocysteine, methylmalonic acid (MMA).

Key facts

Study ID

NCT03061409

Run by

Tufts University

People needed

54

Starts

2016-05-01

Expected to finish

2019-03-15

Last updated by the study team

2019-05-10

Who can join

Age: 45 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• BMI, 20-36 kg/m2
• Taking two or more of the following prescribed drugs (with allowance for a total of more than 6 drug prescriptions):
• diuretic, including: Thiazides: chlorothiazide (Diuril), hydrochlorothiazide (Hydrodiuril), indapamide (Lozol), metolazone (Zaroxolyn), chlorthalidone (Hygroton), methyclothiazide (Enduron); Potassium-sparing: amiloride hydrochloride, spironolactone (Aldactone), triamterene (Dyrenium); Loop: bumetanide (Bumex), furosemide (Lasix), ethacrynate (Edecrin), torsemide (Demadex); and Carbonic anhydrase inhibitors: acetazolamide, methazolamide
• metformin, including: Fortamet, Glucophage, Glumetza, Riomet, ActoPlus Met (with pioglitazone), Avandamet (with rosiglitazone), Glucovance (with glyburide), Janumet (with sitagliptin), Jentadueto (with linagliptin), Kombiglyze extended release (with saxagliptin), Invokamet (with canagliflozin), Metaglip (with glipizide), and PrandiMet (with repaglinide)
• PPI, including: dexlansoprazole (Dexilant, Kapidex), esomeprazole (Nexium) lansoprazole (Prevacid), omeprazole (Prilosec, Zegarid), pantoprazole (Protonix), and rabeprazole (Aciphex)]
• Willing to take the assigned supplement for 16 wk.
• Willing to maintain dietary habit for 16 wk.

You may not qualify if…

• Unusual dietary pattern, including vegan/vegetarian.
• Pregnant or intend to be pregnant.
• Active treatment for cancer of any type longer than 1 y.
• Daily alcoholic intake of more than 14 drinks/wk (168 oz beer, 56 oz wine, 14 oz hard liquor).
• Regular use of any dietary supplements containing vitamins and minerals; however, subjects who are willing to refrain from the use of these supplements for 1 mo prior to their enrollment and throughout the entire study may be considered eligible; subjects will be excluded if they are taking physician prescribed vitamin and/or mineral supplements (This information will be self reported by subjects and documented in the study record of each subject.).
• Values of standard blood biochemistries are critically abnormal based on study physician's discretion.
• Taking >6 prescription or over-the-counter (OTC) drugs on a chronic basis.

Where it is running

• Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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