Effect of Vitamin D Supplementation on Bone Turnover Markers During PrEP in MSM

Completed · Phase 4

Conditions studied: Patient Adherence

In brief

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.

Key facts

Study ID

NCT02367599

Run by

University of California, San Diego

People needed

48

Starts

2014-12-15

Expected to finish

2018-07-11

Last updated by the study team

2020-07-02

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• All subjects must meet CCTG 595 inclusion criteria.

You may not qualify if…

• 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

Where it is running

• University Southern California — Los Angeles, California, United States
• University of California, San Diego — San Diego, California, United States
• Harbor-UCLA Medical Center — Torrance, California, United States

Full record on ClinicalTrials.gov

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