Vitamin and Mineral Supplementation Improves Micronutrient Status in Older Adults
Condition: Nutrient Deficiency
Study type: Interventional

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).
    

Detailed description: 
      The older adults are prone to inadequate nutrition. The prevalence of malnutrition is 5-10%
      among independently living older individuals, 30-60% among institutionalized patients, and
      35-65% among hospitalized geriatric patients. There are many factors that make the elderly
      more susceptible to nutrition inadequacy. Aging itself is associated with a decline in a
      number of physiological functions that can impact nutritional status, including reduced lean
      body mass and a resultant decrease in basal metabolic rate, decreased gastric secretion of
      digestive juices and changes in the oral cavity, sensory function deficits, changes in fluid
      and electrolyte regulation, and chronic diseases. In addition, medications can contribute to
      nutritional inadequacy through many mechanisms, from decreased nutrient absorption in the
      gastrointestinal tract to increased metabolism and from enhanced utilization to rapid
      elimination It has been reported there are >250 drugs that may influence the intake,
      absorption, metabolism and excretion of nutrients. As Americans rely more on prescription
      drugs, many are taking multiple drugs daily, so polypharmacy can increase the likelihood of
      drug-nutrition interactions through additive and synergistic actions.

      Investigators will conduct a randomized, double-blind, placebo controlled, parallel clinical
      trial to test the hypotheis. This trial will include 72 older adults randomized to receive
      either placebo or MVM supplement. Participants will be 45-75 y and have a BMI >20 and <36
      kg/m2. Participants will be receiving regular, chronic pharmacotherapy with ≥2 drugs in the
      following drug classes: a diuretic, metformin and/or proton pump inhibitor medication with
      allowance for a total of less than 7 drug prescriptions. The medication history with one of
      the target drugs will be longer than 6 mo. The total duration of the trial will be ~5 mo,
      including screening and 16 wk of intervention. Participants must maintain their medication
      regimens and dietary habits throughout the intervention. During the intervention phase,
      Participants will take the assigned supplement daily. Blood and urine samples will be
      collected at the baseline, 8 wk, and the end of the 16 wk intervention.

      Participants will be randomly assigned to receive one of the supplements (MVM vs. placebo)
      after their eligibility is confirmed. A randomization scheme will be prepared by a
      biostatistician using a standardized computer program for two treatment groups using a
      parallel design. The nutrient composition of MVM supplement, which will be Pharmavite Nature
      Made Multi for Him 50+ (newly manufactured). A matching placebo product will be manufactured
      by the Natural Alternatives International, Inc. (San Marcos, CA) under the FDA Good
      Manufacturing Practices(GMP) guidelines. The main ingredient of the placebo will be
      microcrystalline cellulose containing 0.5% magnesium stearate. Pharmavite Nature Made Multi
      for Him 50+ has been marketed in US, and both microcrystalline cellulose and magnesium
      stearate have a Generally Recognized As Safe (GRAS) status under FDA Code of Federal
      Regulations (CFR) title 21.
    

Intervention name(s): Pharmavite Nature Made Multi for Him 50+; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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; served as placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention