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NCT03061409 · ClinicalTrials.gov registry record · NA
Vitamin and Mineral Supplementation Improves Micronutrient Status in Older Adults
A NA study, sponsored by Tufts University.
- Completed
- Registry status
- NA
- Development phase
- 54
- Enrollment target
NCT03061409: Completed NA study, sponsored by Tufts University.
NCT03061409 is a NA study that has completed, run by Tufts University. The registered enrollment target is 54 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03061409, a NA study, has completed, sponsored by Tufts University.
- COMPLETED
- Registry status
- NA
- Development phase
- 54 participants
- Enrollment target
Study 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).
Primary Outcome
Vitamin B6, B12, folic acid, thiamine, calcium, magnesium, zinc in plasma will be qunantified.
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Pharmavite Nature Made Multi for Him 50+
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2016-05-01 |
| Est. Completion | 2019-03-15 |
| Phase | NA |
What the finished NCT03061409 record still lists
NCT03061409 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03061409 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03061409 about?
NCT03061409 is a clinical study titled "Vitamin and Mineral Supplementation Improves Micronutrient Status in Older Adults". 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 ran...
What is the current status of trial NCT03061409?
This trial is currently completed. It is a NA study. The enrollment target is 54 participants. The study started on 2016-05-01. Estimated completion is 2019-03-15.
What interventions are being tested in trial NCT03061409?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Pharmavite Nature Made Multi for Him 50+ (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03061409?
This trial is sponsored by Tufts University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03061409's enrollment target sits among peer trials
54 1268th of 2000 higher than 730 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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