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Vitamin DeficiencyNCT03004807

Role of Centrum® Silver® in Improving Micronutrient Status in Older Men

A study testing Centrum Silver Mens' Formula in people with Vitamin Deficiency and Mineral Deficiency, run by Oregon State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Older adults are susceptible to vitamin and mineral deficiencies for a variety of reasons and have an increased demand for many of these micronutrients. Multivitamin/multimineral supplement offer a simple way for adults to improve nutrient intake, but their ability to measurably affect micronutrient status in older… Read more about this study

Who is it for?
Ages 65 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Vitamin Deficiency, Mineral Deficiency, Aging
What is being tested?
Centrum Silver Mens' Formula
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
1 siteUnited States
Study dates
1 Jul 2018to 31 Dec 2021
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 65 years and older
  • Men only
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Participants must be willing to:
  • Consume a multivitamin/mineral supplement or placebo tablet each day during the 6-month study period
  • Fill out online food frequency questionnaires
  • Refrain from taking vitamin and mineral supplements that match micronutrients found in Centrum Silver (including certain antacids, energy drinks, fortified cereals, or nutritional shakes) other than those provided during the study. . Current users of supplements must agree to stop taking these supplements for two months before the study begins.
  • Wear an activity monitor about the wrist continuously for two one-week periods, except when exposed to water, before and during multivitamin supplementation.
  • Give blood samples on 3 separate occasions
  • Participate in cognitive testing procedures

Who cannot join

  • Currently taking supplements as recommended/ordered by a physician to correct a nutritional deficiency, with an exception for vitamins or minerals not found in Centrum Silver (as outlined in a Post-Screen Drug and Supplement Review).
  • Current or recent (two years) history of smoking (tobacco or marijuana)
  • Dysphagia or difficulty swallowing.
  • Bariatric (gastric bypass) surgery or serious chronic illness that might affect absorption of multivitamins or minerals such as Crohn's disease, unmanaged celiac disease, chronic diarrhea, ulcerative colitis, gastritis, or a diagnosis of malabsorption syndrome.
  • A diagnosis of cancer with chemotherapy or radiation treatment during the previous 5 years.
  • Major surgery in the past 6 months or planned major surgery during the duration of the study.
Show all 23Show fewer
  • Prior heart attack, stroke, or heart failure.
  • Uncontrolled stage II hypertension (blood pressure above 159/99 mm Hg).
  • A current diagnosis of kidney, liver, or thyroid disease.
  • Diabetes (Type 1 or Type 2).
  • History of hypoglycemia or low blood sugar.
  • Hb1ac levels > 6.4%.
  • Fail a Post-Screen Drug and Supplement Review.
  • BMI < 18.5 or > 35
  • History of psychological or neurological disorders, or a diagnosis of dementia.
  • Head injury with loss of consciousness of > 5 minutes in the last 5 years.
  • Chronic Migraines - More than fifteen headache days per month over a three-month period of which more than eight are migraines.
  • Score < 26 on the mini-mental state exam.
  • Present treatment for drug or alcohol problems.
  • Habit of taking three or more alcoholic drinks per day.
  • Corrected visual acuity worse than 20/50.
  • Anyone who cannot handwrite a letter or move a computer joystick with one of their hands.
  • Cannot hear well enough to understand spoken instructions.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Linus Pauling Science Center

    Corvallis, Oregon, 97331

Other trials in United States

About this study

Older adults are susceptible to vitamin and mineral deficiencies for a variety of reasons and have an increased demand for many of these micronutrients. Multivitamin/multimineral supplement offer a simple way for adults to improve nutrient intake, but their ability to measurably affect micronutrient status in older adults has never been explored. This study intends to recruit healthy, non-smoking men aged 65 years or older. After meeting entry criteria, subjects will be required to restrict the use of supplements and/or fortified foods. Two months after these restrictions have begun, subjects will come to the clinical research center to take cognitive tests, undergo activity monitoring, provide blood samples for nutrition testing, and take food frequency questionnaires. Subjects will then be randomized into one of two groups - one consuming a multivitamin/multimineral supplement (Centrum Silver Mens Formula); another consuming an inert placebo tablet. Subjects will consume 1 tablet each day for six months. After this period, subjects will return to the clinical research center and repeat cognitive tests, activity monitor, blood sampling, and food frequency questionnaires. These data will be assessed to determine if multivitamin consumption results in changes in various nutrients versus taking a placebo (primary outcomes), and may results in changes lipid and lipoprotein profiles, metabolic health, inflammation, blood pressure or cognitive function (secondary outcomes). The investigators expect that results of this study will add to the general understanding if multivitamin/multimineral formulas can improve nutrition status of older adults, and therefore have the capacity of altering markers of health.

Read the detailed description

Older adults are at increased risk of various chronic diseases, in which inadequate levels of vitamins and minerals may play a significant role, including cardiovascular disease, Alzheimer's disease, liver disease, and cancer. Most adults in the United States do not meet the Recommended Dietary Allowance (RDA) or Adequate Intake (AI) of many vitamins and nutritionally-essential minerals from diet alone, including vitamins A, C, D, E and K, calcium, magnesium, and potassium. Older adults are particularly susceptible to micronutrient inadequacies because of limited absorption, increased requirements, or - in the case of vitamin D - decreased synthetic capacity in the skin. Thus, there is a strong rationale for supplementing the diets of older adults with a multivitamin/multimineral supplement, such as Centrum® Silver®. However, little is currently known about the bioavailability of the Centrum® Silver® formula in this age demographic.

Epidemiological studies and recent clinical trials have shown that use of multivitamin/mineral supplements has beneficial effects on disease risk in men, including those of advanced age. It is assumed that these benefits of multivitamin/mineral supplements are achieved through changes in nutrition status. However, it has never been documented if there are concomitant changes in micronutrient levels in individuals who consume these supplements. Furthermore, changes in nutritional status in older individuals taking multivitamin/multimineral supplements are a subject that has yet to be explored.

Therefore, this study seeks to recruit men who are in generally good health, 65 years of age or older, to assess their vitamin and mineral status before and after six months (approximately 24 weeks) of supplementation with Centrum® Silver®. The investigators hypothesize that consuming multivitamin/multimineral supplements everyday will result in measurable increases in the status of one or more vitamins or minerals in the body. Concentrations of several vitamins and minerals in blood samples will be performed, along with a general assessment of micronutrient status in white blood cells (primary outcomes). To see if these changes in nutrition status impact other aspects of human health, changes in lipid and lipoprotein profiles, antioxidant status, metabolic health, and inflammation and treatment differences in cognitive function will be assessed (secondary outcomes). Centrum® Silver® supplementation may or may not have any effect on these secondary outcomes, when compared to a placebo, unless there are measurable changes in the primary outcomes.

The expectation is that the results of this research will add to a general understanding of multivitamin/mineral supplements and how well they can improve the nutritional status of older adults. By employing direct and functional methods to assay for nutritional content, this study will determine how well these methods correlate and by using both assay methods unique insight into the mechanism(s) whereby multivitamin/multimineral supplements might or might not lead to improvements in health may be ascertained.

Being tested
Centrum Silver Mens' Formula, Control
Keywords
Nutrition, Aging, Multivitamin
Medical subject headings
Avitaminosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Centrum Silver Mens' FormulaDietary supplement

    Also called Centrum Silver Men

    Multivitamin/Multimineral dietary supplement produced for Pfizer for use in older men.

  • ControlOther

    Also called Placebo Comparator

    A matching tablet to the dietary supplement, but without any active ingredients

Study groups in NCT03004807
Study groupRoleWhat they receive
MultivitaminExperimentalCentrum Silver Men's Formula Multivitamin/Multimineral Supplement: 1/day
Receives: Dietary Supplement: Centrum Silver Mens' Formula
ControlPlacebo comparatorMatching tablet to active multivitamin arm: 1/day
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Plasma and Blood Cell Vitamin and Mineral Levels

    Blood samples will be collected at baseline and end of intervention. Plasma levels of beta carotene, pyridoxine (vitamin B6), cobalamin (vitamin B12), ascorbic acid (vitamin C), 25-hydroxy vitamin D, α- tocopherol (vitamin E), and phylloquinone/menaquinones (vitamin K) will be determined. Analyses will be performed for absolute values and values corrected for total lipids where necessary. Folate will be assessed in red blood cells. Minerals analysis by inductively coupled plasma atomic emission spectroscopy (ICP-AES) will be performed in plasma or lymphocytes.

    Measured: Between baseline (visit 3) and 6 months after intervention begins (visit 7)

Secondary outcomes (5)
  1. Lipid Status

    Changes to fasting lipoprotein and triglyceride status

    Measured: Between baseline (visit 3) and 6 months after intervention begins (visit 7)

  2. High Resolution Respirometry

    Isolated white blood cells will be evaluated in the Oroboros Oxygraph (Innsbruck, Austria) to evaluate the capacity of mitochondria to sustain respiration/energy demands

    Measured: Between baseline (visit 3) and 6 months after intervention begins (visit 7)

  3. Cognitive abilities

    Cognitive abilities will be assessed by the following NIH Toolbox measures: Picture Vocabulary, Flanker Inhibitory Control and Attention Test, Sorting Working Memory Test, Dimensional Change Card Sort Test, Pattern Completion Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition Test. The individual test scores are based on time and accuracy, will be normalized to scaled scores, and averaged to obtain a Fluid Cognition Composite score, as calculated by the NIH Toolbox scoring algorithms. Significant changes in total score after intervention, or between intervention and control groups will be recorded. Logical Memory will be tested with recall of narrative story both immediate and delayed as described in Wechsler Memory Scale-IV Protocol. Additionally, a "Head-Toes-Knees-Shoulders Task" that combines physical activity with processing speed and accuracy will also be assessed at the completion of each session.

    Measured: Between cognitive baseline (visit 2) and 6 months after intervention begins (visit 6)

  4. Spatial memory as assessed by a virtual water maze

    A computerized environment will be presented for the subject that can be navigated with a joystick. The goal is to find a hidden platform based on spatial clues. Search accuracy for the target platform in the environment will be assessed between trials. Changes in proximity to the platform will be compared between successive trials in an individual, and also between individuals in the placebo control and multivitamin intervention groups.

    Measured: At visit 6, approximately 6 months after intervention begins, 1 week before visit 7

  5. Crystallized cognitive abilities

    Crystallized abilities will be assessed with NIH Toolbox Oral Reading Recognition Test and NIH Toolbox Picture Vocabulary Test. The individual test scores will be determined after adjusting for computer adaptive testing, normalized to scaled scores, and averaged to obtain a Crystallized Cognition Composite score, as calculated by the NIH Toolbox scoring algorithms. Significant changes in total score after intervention, or between intervention and control groups will be recorded.

    Measured: 1 week before intervention begins (visit 2) and 1 week before intervention ends (visit 6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2016 (estimated)
  2. Study start1 Jul 2018
  3. Primary completion31 May 2021
  4. Study completion31 Dec 2021

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03004807
Sponsor's protocol ID
WI211838
Other IDs
7158
Status last verified
Jun 2025
First submitted
8 Dec 2016
Last updated
8 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Researchers interested in study data may contact the study principal investigators to request access. Data requests must be submitted in writing for approval by qualified individuals and will be reviewed by study investigators.

Publications

  • Michels AJ, Butler JA, Uesugi SL, Lee K, Frei BB, Bobe G, Magnusson KR, Hagen TM. Multivitamin/Multimineral Supplementation Prevents or Reverses Decline in Vitamin Biomarkers and Cellular Energy Metabolism in Healthy Older Men: A Randomized, Double-Blind, Placebo-Controlled Study. Nutrients. 2023 Jun 9;15(12):2691. doi: 10.3390/nu15122691.

    PubMed 37375594

Questions about this trial

What is this clinical trial studying?

A study testing Centrum Silver Mens' Formula in people with Vitamin Deficiency and Mineral Deficiency, run by Oregon State 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 23 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 8 Jun 2025. 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?

Changes in Plasma and Blood Cell Vitamin and Mineral Levels (time frame: Between baseline (visit 3) and 6 months after intervention begins (visit 7)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03004807, which also lists 1 linked publication.

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 8 Jun 2025.

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