Vitamin D in HIV-Infected Patients on HAART

Not Applicable

Completed

• Conditions: HIV; Vitamin D Deficiency
• Interventions: Dietary Supplement: Vitamin D

• Registration Number: NCT01250899
• Lead Sponsor: University of California, Los Angeles

Brief Summary

This is a research study to look at vitamin D deficiency (low levels) in men and women with HIV. As part of your regular medical care, you will be screened for vitamin D deficiency. If your levels are low, and you choose to start using vitamin D supplements, the investigators would like to take some blood before and after you start using vitamin D to see how this affects your levels of HIV, T cells, cholesterol, and other blood levels. The investigators will provide you with vitamin D supplements for the first 24 weeks (6 months) of the study. If you and your physician decide that you should continue taking vitamin D supplements after that time, you will be responsible for purchasing your own vitamin D supplements.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-30
• Study First Submitted QC: 2010-11-30
• Study First Posted: 2010-12-01
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2014-08-25
• Results First Submitted QC: 2014-08-25
• Results First Posted: 2014-09-05
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-24
• Last Update Posted: 2014-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• HIV-positive men and women age 18 and older.
• HIV-1 RNA documented to be < 200 copies/mL on their current ART regimen, with supporting viral load documentation in the 24 weeks prior to study entry.
• Subjects must receive primary HIV care at the UCLA CARE center.
• Subjects must be undergoing screening for vitamin D deficiency by their primary care provider at the time of study entry, or have undergone vitamin D screening in the 90 days prior to consent without yet initiating vitamin D supplementation (for insufficient subjects).
• Ability and willingness of subject to provide informed consent

Exclusion Criteria

• Use of vitamin D supplementation (not including 400 IU daily, the amount in a standard multivitamin) at the time of screening.
• HIV-infected subjects not on ART.
• HIV-infected subjects not suppressed on their current ART regimen (HIV-1 RNA > 200 copies/mL in the 6 months prior to screening).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D Insufficient	Vitamin D	HIV-infected men and women with HIV-1 viral load \<200 copies /mL on stable ART and 25(OH)D level \<30ng/mL receive 50,000 IU twice weekly for 5 weeks followed by 2000 IU daily to complete 12 weeks.

Primary Outcome Measures

Name	Time	Method
Success Rate in Achieving a 25(OH)D Level ≥30ng/mL After 12 Weeks of Oral Vitamin D Supplementation.	12 weeks	Percentage of participants successfully repleted to 25(OH)D ≥30ng/mL after 12 weeks of oral vitamin D supplementation.

Trial Locations

Locations (1)

UCLA CARE Center; 🇺🇸 Los Angeles, California, United States