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NCT Number: NCT02367599

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 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.

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Key information

Conditions

Patient Adherence Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

University Southern California, Los Angeles, California, United States

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About this study

A total of 50 HIV-uninfected men who have sex with men (MSM) and male to female (M to F) transgender individuals already enrolled in CCTG 595 will be offered participation in the sub-study at Week 24 of the main study. All subjects enrolled into the sub-study will be provided Vitamin D 4000 IU/day supplements in addition to their PrEP at Weeks 24 and 36; clinic visits will proceed normally per main study protocol. Upon completion of the sub-study subjects will continue on the main study.

The primary endpoint, bone turnover markers, will be measured from Week 24 to Week 48 via plasma samples collected through the main study. Concurrent controls who are not enrolled in the vitamin D substudy who are reporting supplementation with < 400 IU of vitamin D/day will be matched 1:1 by randomization arm in the CCTG 595 main study (text messaging arm vs. standard of care), age (± 5 years), race/ethnicity, season of study entry, and BMI (± 3 kg/m2).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D supplement

Drug

Subjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 Weeks.

Primary outcomes

  1. Change in Total Procollagen Type 1 N-terminal Propeptide (a Marker of Bone Formation) [P1NP] Levels

    Time frame: Weeks 24-48

    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

Secondary outcomes

  1. Change in CTX-1 Levels

    Time frame: Weeks 24-48

    To compare the change in CTX-1 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

  2. Change in PTH Levels

    Time frame: Weeks 24-48

    To compare the change in PTH 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

  3. Change in 25-OH Vitamin D3 Levels

    Time frame: Weeks 24-48

    To compare the change in 25-OH vitamin D3 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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • California HIV/AIDS Research Program
  • City of Long Beach Department of Health and Human Services
  • Gilead Sciences
  • University of California, Los Angeles
  • University of Southern California

Registry information

Official study title

Effect of Vitamin D Supplementation on Bone Turnover Markers During Tenofovir-Emtricitibine Pre-Exposure Prophylaxis in Men Who Have Sex With Men; A Sub-study of CCTG 595

Acronym: CCTG595VitD

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 20, 2015
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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