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

Patient Adherence Clinical Trial

— CCTG595VitD  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367599
• Other study ID #: CCTG 595 Vitamin D Sub-Study
• Status: Completed
• Phase: Phase 4
• Start date: December 15, 2014
• Est. completion date: July 11, 2018

Study information

• Verified date: June 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 11, 2018
• Est. primary completion date: June 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Adherence

Intervention

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

Locations

Country	Name	City	State
United States	University Southern California	Los Angeles	California
United States	University of California, San Diego	San Diego	California
United States	Harbor-UCLA Medical Center	Torrance	California

Sponsors (6)

Lead Sponsor	Collaborator
University of California, San Diego	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Procollagen Type 1 N-terminal Propeptide (a Marker of Bone Formation) [P1NP] Levels	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	Weeks 24-48
Secondary	Change in CTX-1 Levels	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	Weeks 24-48
Secondary	Change in PTH Levels	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	Weeks 24-48
Secondary	Change in 25-OH Vitamin D3 Levels	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	Weeks 24-48