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NCT02367599 · ClinicalTrials.gov registry record · Phase 4
Effect of Vitamin D Supplementation on Bone Turnover Markers During PrEP in MSM
A Phase 4 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 4
- Development phase
- 48
- Enrollment target
NCT02367599: Completed Phase 4 study, sponsored by University of California, San Diego.
NCT02367599 is a Phase 4 study that has completed, run by University of California, San Diego. The registered enrollment target is 48 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02367599, a Phase 4 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 48 participants
- Enrollment target
Study Summary
CCTG 595 is an open-label clinical trial of the effect of a text messaging intervention vs. standard of care on adherence to Truvada as PrEP in MSM at increased risk for HIV infection (ClinicalTrials.gov Identifier: NCT01761643). Eligible subjects for this matched case control substudy will receive vitamin D 4000 IU/day for 24 weeks, from week 24 through week 48. In CCTG 595, plasma from participants are being collected and stored at entry and every 12 weeks. These plasma samples will be used to measure P1NP, CTX, PTH, and vitamin D levels in both cases and controls at entry, week 24, and week 48.
Primary Outcome
To compare the change in P1NP levels from Week 24 through Week 48 among subjects (cases) who receive vitamin D 4000 IU/day to the change in levels seen in matched unsupplemented controls
Interventions
- DRUG Vitamin D Supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2014-12-15 |
| Est. Completion | 2018-07-11 |
| Phase | Phase 4 |
What the finished NCT02367599 record still lists
NCT02367599 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Vitamin D Supplement is the first listed.
NCT02367599 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02367599 about?
NCT02367599 is a clinical study titled "Effect of Vitamin D Supplementation on Bone Turnover Markers During PrEP in MSM". CCTG 595 is an open-label clinical trial of the effect of a text messaging intervention vs. standard of care on adherence to Truvada as PrEP in MSM at increased risk for HIV infection (ClinicalTrials.gov Identifier: NCT01761643). Eligible subjects for this matched case control substudy will receive ...
What is the current status of trial NCT02367599?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 48 participants. The study started on 2014-12-15. Estimated completion is 2018-07-11.
What interventions are being tested in trial NCT02367599?
The interventions under investigation include: Vitamin D Supplement (DRUG).
Who is sponsoring clinical trial NCT02367599?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02367599's enrollment target sits among peer trials
48 1331st of 2000 higher than 653 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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