Vitamin and Mineral Supplementation Improves Micronutrient Status in Older Adults
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|ClinicalTrials.gov Identifier: NCT03061409|
Recruitment Status : Unknown
Verified February 2017 by Oliver Chen, Tufts University.
Recruitment status was: Recruiting
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Nutrient Deficiency||Dietary Supplement: Pharmavite Nature Made Multi for Him 50+ Dietary Supplement: Placebo||Not Applicable|
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 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 GRAS status under FDA Code of Federal Regulations (CFR) title 21.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||July 2018|
Experimental: Pharmavite Nature Made Multi for Him 50+
A supplement containing vitamins and minerals
Dietary Supplement: Pharmavite Nature Made Multi for Him 50+
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
Dietary Supplement: Placebo
served as placebo
- 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.
- Change from Baseline redox status at 16 weeks [ Time Frame: 0 and 16 weeks ]plasma biomarkers of free radical attacked products will be measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03061409
|Contact: Oliver Chenemail@example.com|
|United States, Massachusetts|
|Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University||Recruiting|
|Boston, Massachusetts, United States, 02111|
|Contact: Kimberly Dupiton, BA 617-556-3012 Kimberly.Dupiton@tufts.edu|
|Principal Investigator:||Oliver Chen, PhD||Tufts University|