Phase 4
Completed N=96
Effect of Vitamin D Supplementation on Bone Turnover Markers During PrEP in MSM
Patient Adherence
Source: ClinicalTrials.gov NCT02367599 ↗
Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Change in Total Procollagen Type 1 N-terminal Propeptide (a Marker of Bone Formation) [P1NP] Levels — -27.6; -2.5 pg/mL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Procollagen Type 1 N-terminal Propeptide (a Marker of Bone Formation) [P1NP] Levels |
-27.6; -2.5 | — |
| SECONDARY Change in CTX-1 Levels |
0.03; 0.29 | — |
| SECONDARY Change in PTH Levels |
57.3; 108.4 | — |
| SECONDARY Change in 25-OH Vitamin D3 Levels |
4.4; -0.9 | — |
Eligibility Criteria
Inclusion Criteria
- All subjects must meet CCTG 595 inclusion criteria.
Exclusion Criteria
- All subjects must meet CCTG 595 exclusion criteria.
- Current or prior use of bisphosphonate therapy.
- Current use of Vitamin D supplements greater than 400 IU/day.
- Current use of androgenic hormones or growth hormones.
- History of nephrolithiasis (kidney stones).
- History of fragility fracture.
- No use of tenofovir prior to entry into CCTG 595
Data sourced from ClinicalTrials.gov (NCT02367599). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.