CompletedEarly Phase 1

A Pilot Study to Examine the Effects of Vitamin D Supplementation on Mitochondrial Bioenergetics in Older Adults

United States15 participantsStarted 2014-10

Plain-language summary

This pilot study is a 4-month open label trial in 15 older (65-89 yrs) men and women with initial 25(OH)D concentrations of 12-\<18 ng/mL to explore the effect of increasing 25(OH)D concentrations to ≥30 ng/mL through vitamin D3 supplementation on changes in mitochondrial bioenergetics. We will assess the bioenergetic profile of blood cells isolated mitochondria, and muscle fibers as well as the expression of mitochondrial proteins and regulators of mitochondria biogenesis before and after supplementation. All participants will be given vitamin D3 (4,000 IU/d) for 4 months.

Who can participate

Age range

65 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * SPPB score of 10 or less * initial serum 25(OH)D concentration of 12-17.9 ng/mL * not dependent on a walker * willing to provide informed consent and to adhere to the protocol * not involved in another behavioral, exercise, or investigational drug intervention study * self-reported physical performance difficulty * were screened for the EVIDENCE study within the last 2 months Exclusion Criteria: * serious or uncontrolled chronic disease * evidence of impaired cognitive function (MoCA\<18) * taking prescription vitamin D2 or taking \>1000 IU/day of vitamin D3 from all sources; taking an oral corticosteroid; taking hormone replacement therapy * inability or contraindications to consume daily vitamin D supplements * knee or hip surgery within the last 6 months or planned knee or hip surgery within the next year * not willing or eligible to undergo a muscle biopsy (on blood thinners) * weight loss of greater than or equal to 5% in the past 3 months * BMI \> 40kg/m2 * eye surgery within the past month or planned within the next month * if the PI feels the participant is unlikely to follow the protocol

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Respirometric profiling

Timeframe: 4 months

Trial details

NCT IDNCT02445066

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-08

View on ClinicalTrials.gov More Low 25-hydroxyvitamin D Concentrations trials