Vitamin and Mineral Supplementation Improves Micronutrient Status in Older Adults

NCT03061409 | Completed

• 1 other identifier: 2900
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Nutrient Deficiency

Outcome Measures

Primary Outcomes (1)

• Change from Baseline nutrient status at 16 weeks

  Vitamin B6, B12, folic acid, thiamine, calcium, magnesium, zinc in plasma will be qunantified.

  0 and 16 weeks

Secondary Outcomes (1)

• Change from Baseline redox status at 16 weeks

  0 and 16 weeks

Study Arms (2)

Pharmavite Nature Made Multi for Him 50+

EXPERIMENTAL

A supplement containing vitamins and minerals

Dietary Supplement: Pharmavite Nature Made Multi for Him 50+

placebo

PLACEBO COMPARATOR

tablets contain microcrystalline cellulose containing 0.5% magnesium stearate

Dietary Supplement: Placebo

Interventions

Pharmavite Nature Made Multi for Him 50+ DIETARY_SUPPLEMENT

To examine whether one tablet a day of Pharmavite Nature Made Multi for Him 50+ will increase micro-nutrient status in older people taking multiple medications as compared to placebo

Pharmavite Nature Made Multi for Him 50+

Placebo DIETARY_SUPPLEMENT

served as placebo

placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Tufts University: lead
• MB Clinical Research and Consulting LLC: collaborator

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University

Boston, Massachusetts, 02111, United States

Location

Study Officials

• Jeffrey Blumberg, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: February 23, 2017
• Study Start: May 1, 2016
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: May 10, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)