Nutrient DeficiencyNCT03061409
Vitamin and Mineral Supplementation Improves Micronutrient Status in Older Adults
A study testing Pharmavite Nature Made Multi for Him 50+ in people with Nutrient Deficiency, run by Tufts University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Nutrient Deficiency
- What is being tested?
- Pharmavite Nature Made Multi for Him 50+
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2016to 15 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University
Boston, Massachusetts, 02111
About this study
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).
Read the 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.
- Conditions
- Nutrient Deficiency
- Being tested
- Pharmavite Nature Made Multi for Him 50+, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboDietary supplement
served as placebo
| Study group | Role | What they receive |
|---|---|---|
| Pharmavite Nature Made Multi for Him 50+ | Experimental | A supplement containing vitamins and minerals Receives: Dietary Supplement: Pharmavite Nature Made Multi for Him 50+ |
| placebo | Placebo comparator | tablets contain microcrystalline cellulose containing 0.5% magnesium stearate Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline nutrient status at 16 weeks
Vitamin B6, B12, folic acid, thiamine, calcium, magnesium, zinc in plasma will be qunantified.
Measured: 0 and 16 weeks
Secondary outcomes (1)
Change from Baseline redox status at 16 weeks
plasma biomarkers of free radical attacked products will be measured.
Measured: 0 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 May 2016
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrient DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Midwest Biomedical Research
- Responsible party
- Principal investigator, Jeffrey Blumberg, Tufts University
- Investigators
- Jeffrey Blumberg, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061409
- Sponsor's protocol ID
- 2900
- Status last verified
- May 2019
- First submitted
- 12 Jan 2017
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin and Mineral Supplementation Improves Micronutrient Status in Older Adults
- ClinicalTrials.gov ID
- NCT03061409
- Acronym / sponsor ID
- 2900
- Conditions
- Nutrient Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Midwest Biomedical Research
- Study start
- 1 May 2016 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmavite Nature Made Multi for Him 50+ | Experimental | Dietary Supplement: Pharmavite Nature Made Multi for Him 50+A supplement containing vitamins and minerals |
| placebo | Placebo comparator | Dietary Supplement: Placebotablets contain microcrystalline cellulose containing 0.5% magnesium stearate |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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):
- Willing to take the assigned supplement for 16 wk.
- Willing to maintain dietary habit for 16 wk.
Key exclusion criteria (7 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dietary supplement | Pharmavite Nature Made Multi for Him 50+ |
| Placeboserved as placebo | Dietary supplement | placebo |
Primary outcome
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.
1 secondary outcome
Change from Baseline redox status at 16 weeks
Time frame: 0 and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Individual participant dataSharing planned: No
Related trials for Nutrient Deficiency
Enrolling by invitation
PROmega Pilot Study of Clinic-based DHA Blood Screening in Early Pregnancy
Nutrient Deficiency
Recruiting
Implementation of Multiple Micronutrient Supplementation (MMS) for Pregnant Women in Uganda
Nutrient Deficiency
RecruitingObservational study
Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories
Malnutrition Pregnancy, Malnutrition in Children
Recruiting
Conversion to SADI-S, RYGB or OAGB After Failed Sleeve
Weight Loss, Bariatric Surgery Candidate
Enrolling by invitationObservational study
Challenges in Achieving Adequate Dietary Status of Women
Nutritional Status, Nutrient Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Blumberg, PhD principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmavite Nature Made Multi for Him 50+ in people with Nutrient Deficiency, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline nutrient status at 16 weeks (time frame: 0 and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.