- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03061409
Vitamin and Mineral Supplementation Improves Micronutrient Status in Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02111
- Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pharmavite Nature Made Multi for Him 50+
A supplement containing vitamins and minerals
|
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
|
Placebo Comparator: placebo
tablets contain microcrystalline cellulose containing 0.5% magnesium stearate
|
served as placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline nutrient status at 16 weeks
Time Frame: 0 and 16 weeks
|
Vitamin B6, B12, folic acid, thiamine, calcium, magnesium, zinc in plasma will be qunantified.
|
0 and 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline redox status at 16 weeks
Time Frame: 0 and 16 weeks
|
plasma biomarkers of free radical attacked products will be measured.
|
0 and 16 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeffrey Blumberg, PhD, Tufts University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2900
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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