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NCT02445066 · ClinicalTrials.gov registry record · Early Phase 1
A Pilot Study to Examine the Effects of Vitamin D Supplementation on Mitochondrial Bioenergetics in Older Adults
A Early Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
NCT02445066: Completed Early Phase 1 study, sponsored by Wake Forest University Health Sciences.
NCT02445066 is a Early Phase 1 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 15 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02445066, a Early Phase 1 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
Study 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.
Primary Outcome
Respirometry of isolated mitochondria will be performed in order to examine intrinsic mitochondrial function (type1). Respirometry of permeabilized muscle fibers will be performed to assess type 2 alterations in mitochondrial function. Mitochondrial mass and biogenesis will be determined by western blot analysis. Blood based bioenergetic profiling - PBMC's, monocytes, lymphocytes, and platelets will be separated from whole blood and assessed for basal respiration, maximal respiration, ATP linked
Interventions
- DIETARY_SUPPLEMENT Vitamin D3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-10 |
| Est. Completion | 2017-08 |
| Phase | Early Phase 1 |
What the finished NCT02445066 record still lists
NCT02445066 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Vitamin D3 is the first listed.
NCT02445066 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02445066 about?
NCT02445066 is a clinical study titled "A Pilot Study to Examine the Effects of Vitamin D Supplementation on Mitochondrial Bioenergetics in Older Adults". 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 asse...
What is the current status of trial NCT02445066?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2014-10. Estimated completion is 2017-08.
What interventions are being tested in trial NCT02445066?
The interventions under investigation include: Vitamin D3 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02445066?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02445066's enrollment target sits among peer trials
15 1404th of 2000 higher than 527 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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