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Effect of Vitamin D Supplementation on Bone Turnover Markers During PrEP in MSM (CCTG595VitD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02367599
Recruitment Status : Completed
First Posted : February 20, 2015
Results First Posted : July 2, 2020
Last Update Posted : July 2, 2020
Sponsor:
Collaborators:
University of Southern California
University of California, Los Angeles
City of Long Beach Department of Health and Human Services
California HIV/AIDS Research Program
Gilead Sciences
Information provided by (Responsible Party):
Sheldon Morris, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Patient Adherence Drug: Vitamin D Supplement Phase 4

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : December 15, 2014
Actual Primary Completion Date : June 13, 2018
Actual Study Completion Date : July 11, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: Vitamin D Supplement + PrEP
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
Subjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 Weeks.

No Intervention: PrEP Only
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02367599


Locations
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United States, California
University Southern California
Los Angeles, California, United States, 90033
University of California, San Diego
San Diego, California, United States, 92103
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Sponsors and Collaborators
University of California, San Diego
University of Southern California
University of California, Los Angeles
City of Long Beach Department of Health and Human Services
California HIV/AIDS Research Program
Gilead Sciences
Investigators
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Study Chair: Michael P Dube, MD CCTG, USC
Principal Investigator: Sheldon Morris, MD UC San Diego AntiViral Research Center (AVRC)
  Study Documents (Full-Text)

Documents provided by Sheldon Morris, University of California, San Diego:
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Responsible Party: Sheldon Morris, Clinical Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02367599    
Other Study ID Numbers: CCTG 595 Vitamin D Sub-Study
First Posted: February 20, 2015    Key Record Dates
Results First Posted: July 2, 2020
Last Update Posted: July 2, 2020
Last Verified: June 2020
Keywords provided by Sheldon Morris, University of California, San Diego:
PrEP
Pre exposure Prophylaxis
Truvada
CCTG
595
Vitamin D
Bone mineral density
Additional relevant MeSH terms:
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Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents