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

NCT02367599 | Completed Phase 4 Results

• 1 other identifier: CCTG 595 Vitamin D Sub-Study
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

PrEP; Pre exposure Prophylaxis; Truvada; CCTG; 595; Vitamin D; Bone mineral density

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in CTX-1 Levels

  Weeks 24-48

• Change in PTH Levels

  Weeks 24-48

• Change in 25-OH Vitamin D3 Levels

  Weeks 24-48

Study Arms (2)

Vitamin D Supplement + PrEP

ACTIVE COMPARATOR

Subjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 Weeks in addition to their PrEP provided through the main study.

Drug: Vitamin D Supplement

PrEP Only

NO INTERVENTION

Subjects not enrolled into this sub-study will continue receiving PrEP through the main study. Subjects taking unsupplemented PrEP may still be used as matched controls to sub-study subjects.

Interventions

Vitamin D Supplement DRUG

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

Vitamin D Supplement + PrEP

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (3)

University Southern California

Los Angeles, California, 90033, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sheldon Morris
• Organization: UCSD

shmorris@ucsd.edu

6195438080

Study Officials

• Michael P Dube, MD

  CCTG, USC

  STUDY CHAIR

• Sheldon Morris, MD

  UC San Diego AntiViral Research Center (AVRC)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 20, 2015
• Study Start: December 15, 2014
• Primary Completion: June 13, 2018
• Study Completion: July 11, 2018
• Last Updated: July 2, 2020
• Results First Posted: July 2, 2020

Record last verified: 2020-06

Locations

US (3)