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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 is a Phase 3 study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 24 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02920502
The ClinicalTrials.gov registry entry for NCT02920502 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Arm 2: cholecalciferol 50,000 IU is the first listed.
NCT02920502 reports 0 study locations.
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.
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