Trial Outcomes & Findings for Effect of Vitamin D Supplementation on Bone Turnover Markers During PrEP in MSM (NCT NCT02367599)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

48 participants

Primary outcome timeframe

Weeks 24-48

Results posted on

2020-07-02

Participant Flow

Participants in the parent trial (CCTG 595) were offered the opportunity to enroll in this sub-study providing Vitamin D supplementation to HIV pre-exposure prophylaxis (PrEP).

48 enrolled, 48 matched from parent study. Total 96 evaluated participants.

Participant milestones

Participant milestones
Measure	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 parent trial.	PrEP Only Matched Group A cohort of parent trial participants will be selected to match subjects enrolled in the sub-study to serve as comparative controls.
Overall Study STARTED	48	48
Overall Study COMPLETED	48	48
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin D Supplement + PrEP n=48 Participants 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.	PrEP Only Matched Group n=48 Participants A cohort of main-study participants will be selected to match subjects enrolled in the sub-study to serve as controls for comparison.	Total n=96 Participants Total of all reporting groups
Age, Continuous	33.5 years n=5 Participants	33.0 years n=7 Participants	33.2 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	48 Participants n=7 Participants	96 Participants n=5 Participants
Race/Ethnicity, Customized White	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Race/Ethnicity, Customized Black	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Multiracial	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	16 Participants n=5 Participants	8 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment United States	48 participants n=5 Participants	48 participants n=7 Participants	96 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Vitamin D Supplement + PrEP n=48 Participants Subjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 weeks in addition to their PrEP provided through the parent trial.	PrEP Only Matched Group n=48 Participants A cohort of parent trial participants will be selected to match subjects enrolled in the sub-study to serve as comparative controls.
Change in Total Procollagen Type 1 N-terminal Propeptide (a Marker of Bone Formation) [P1NP] Levels	-27.6 pg/mL Standard Deviation 49.9	-2.5 pg/mL Standard Deviation 40.2

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Vitamin D Supplement + PrEP n=48 Participants Subjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 weeks in addition to their PrEP provided through the parent trial.	PrEP Only Matched Group n=48 Participants A cohort of parent trial participants will be selected to match subjects enrolled in the sub-study to serve as comparative controls.
Change in CTX-1 Levels	0.03 ng/mL Standard Deviation 1.12	0.29 ng/mL Standard Deviation 2.10

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Vitamin D Supplement + PrEP n=48 Participants Subjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 weeks in addition to their PrEP provided through the parent trial.	PrEP Only Matched Group n=48 Participants A cohort of parent trial participants will be selected to match subjects enrolled in the sub-study to serve as comparative controls.
Change in PTH Levels	57.3 pg/mL Standard Deviation 128.9	108.4 pg/mL Standard Deviation 210.5

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Vitamin D Supplement + PrEP n=48 Participants Subjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 weeks in addition to their PrEP provided through the parent trial.	PrEP Only Matched Group n=48 Participants A cohort of parent trial participants will be selected to match subjects enrolled in the sub-study to serve as comparative controls.
Change in 25-OH Vitamin D3 Levels	4.4 ng/mL Standard Deviation 16.2	-0.9 ng/mL Standard Deviation 13.7

Adverse Events

Vitamin D Supplement + PrEP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PrEP Only Matched Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sheldon Morris

UCSD

Phone: 6195438080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place