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NCT02920502 · ClinicalTrials.gov registry record · Phase 3
Effect of a One Time Dose of Cholecalciferol on Serum Concentration of 25-Hydroxyvitamin D and Macrophages
A Phase 3 study, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
NCT02920502: Completed Phase 3 study, sponsored by University Hospitals Cleveland Medical Center.
NCT02920502 is a Phase 3 study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 24 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02920502, a Phase 3 study, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
Study Summary
Optimal Vitamin D dosing to obtain adequate serum concentrations of 25-hydroxyvitamin D (25OHD) is controversial. The optimal dose and dosing interval is unknown, and the tendency over the last few years is to give higher, less frequent doses. Disease-specific dosing is of interest, and there may be optimal serum concentration targets based on disease process. The best evidence so far is for optimal bone health, where most experts agree that 25OHD serum concentration should be above 30 ng/ml. There is mounting evidence that Vitamin D therapy will reduce inflammatory response and macrophage activation. The optimal dosing needed to decrease the inflammatory response is unclear, although our recent mouse model has demonstrated that a onetime high dose is effective. The investigators therefore hypothesize that a one-time high dose of cholecalciferol will be effective in suppression of macrophage production of tumor necrosis factor-alpha (TNFa) and inducible nitric oxide synthase (iNOS). The purpose of this pilot study is to assess the optimum dosage for the most macrophage suppression.
Primary Outcome
MED testing \& Recovery from UV-induced erythema and edema before a one time dose of cholecalciferol
Interventions
- DIETARY_SUPPLEMENT Arm 2: cholecalciferol 50,000 IU
- DIETARY_SUPPLEMENT Arm 3: cholecalciferol 100,000 IU
- DIETARY_SUPPLEMENT Arm 4: cholecalciferol 200,000 IU
- OTHER Arm 1: Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
What the finished NCT02920502 record still lists
NCT02920502 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 4 interventions - of which Arm 2: cholecalciferol 50,000 IU is the first listed.
NCT02920502 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02920502 about?
NCT02920502 is a clinical study titled "Effect of a One Time Dose of Cholecalciferol on Serum Concentration of 25-Hydroxyvitamin D and Macrophages". Optimal Vitamin D dosing to obtain adequate serum concentrations of 25-hydroxyvitamin D (25OHD) is controversial. The optimal dose and dosing interval is unknown, and the tendency over the last few years is to give higher, less frequent doses. Disease-specific dosing is of interest, and there may be...
What is the current status of trial NCT02920502?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2013-06. Estimated completion is 2015-08.
What interventions are being tested in trial NCT02920502?
The interventions under investigation include: Arm 2: cholecalciferol 50,000 IU (DIETARY_SUPPLEMENT), Arm 3: cholecalciferol 100,000 IU (DIETARY_SUPPLEMENT), Arm 4: cholecalciferol 200,000 IU (DIETARY_SUPPLEMENT), Arm 1: Placebo (OTHER).
Who is sponsoring clinical trial NCT02920502?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02920502's enrollment target sits among peer trials
24 1943rd of 2000 higher than 49 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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