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

NCT02367599 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-07-02

Study results available
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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.

Conditions

  • Patient Adherence

Interventions

DRUG

Vitamin D Supplement

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

Sponsors & Collaborators

Principal Investigators

  • Michael P Dube, MD · CCTG, USC

  • Sheldon Morris, MD · UC San Diego AntiViral Research Center (AVRC)

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-15
Primary Completion
2018-06-13
Completion
2018-07-11

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02367599 on ClinicalTrials.gov