Trial Outcomes & Findings for Vitamin D in HIV-Infected Patients on HAART (NCT NCT01250899)

Results Overview

Percentage of participants successfully repleted to 25(OH)D ≥30ng/mL after 12 weeks of oral vitamin D supplementation.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

122 participants

Primary outcome timeframe

12 weeks

Results posted on

2014-11-25

Participant Flow

Participant milestones

Participant milestones
Measure	Vitamin D Sufficient HIV-infected men and women on stable ART underwent routine serum 25(OH)D screening. Persons with HIV-1 RNA \<200 copies/mL and reported taking daily vitamin D \<400 IU were eligible to participate. Subjects with 25(OH)D ≥30ng/mL had a baseline visit only, and did not receive vitamin D supplementation.	Vitamin D Insufficient HIV-infected men and women on stable ART underwent routine serum 25(OH)D screening. Persons with HIV-1 RNA \<200 copies/mL and reported taking daily vitamin D \<400 IU were eligible to participate. Subjects with 25(OH)D \<30ng/mL received open-label, oral vitamin D3 50,000 IU twice weekly for 5 weeks, then 2000 IU daily to complete 12 weeks. Serum 25(OH)D levels were measured at baseline, 12 weeks and 24 weeks.
Overall Study STARTED	40	82
Overall Study COMPLETED	40	82
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vitamin D in HIV-Infected Patients on HAART

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin D Sufficient n=40 Participants HIV-infected men and women on stable ART with HIV-1 RNA \<200 copies/mL and reported taking daily vitamin D \<400 IU were eligible to participate. Subjects with 25(OH)D ≥30ng/mL had a baseline visit only, and did not receive vitamin D supplementation.	Vitamin D Insufficient n=82 Participants HIV-infected men and women on stable ART with HIV-1 RNA \<200 copies/mL and reported taking daily vitamin D \<400 IU were eligible to participate. Subjects with 25(OH)D \<30ng/mL received open-label, oral vitamin D3 50,000 IU twice weekly for 5 weeks, then 2000 IU daily to complete 12 weeks.	Total n=122 Participants Total of all reporting groups
Age, Continuous	49 years n=5 Participants	48 years n=7 Participants	48 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	78 Participants n=7 Participants	116 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: After 12 weeks of oral vitamin D supplementation, serum 25(OH)D levels were measured in the Vitamin D Insufficient arm. 81% (n=66) of insufficient persons achieved 25(OH)D ≥30ng/mL (p=0.32 vs. historical controls).

Percentage of participants successfully repleted to 25(OH)D ≥30ng/mL after 12 weeks of oral vitamin D supplementation.

Outcome measures

Outcome measures
Measure	Vitamin D Insufficient n=82 Participants Baseline 25(OH)D \<30 ng/mL received 12 weeks of oral vitamin D supplementation. Serum 25(OH)D levels were measured at baseline, 12 weeks and 24 weeks.
Success Rate in Achieving a 25(OH)D Level ≥30ng/mL After 12 Weeks of Oral Vitamin D Supplementation.	81 percentage of participants Interval 70.0 to 88.0

Adverse Events

Vitamin D Insufficient

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

Dr Jordan Lake

University of California, Los Angeles

Phone: 310-557-2273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place