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

Completed · Early Phase 1

Conditions studied: Low 25-hydroxyvitamin D Concentrations

In brief

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.

Key facts

Study ID: NCT02445066
Run by: Wake Forest University Health Sciences
People needed: 15
Starts: 2014-10-01
Expected to finish: 2017-08-01
Last updated by the study team: 2018-08-15

Who can join

Age: 65 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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