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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-15

Study Completion Date

2018-07-11

Brief Summary

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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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Detailed Description

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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).

Conditions

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Patient Adherence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Vitamin D Supplement

Intervention Type DRUG

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vitamin D Supplement

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes