Vitamin D in HIV-Infected Patients on HAART

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Vitamin D Deficiency; HIV

Treatments: Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT01250899

CARE Vitamin D

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Vitamin D Sufficient

No Intervention group

Description:

HIV-infected men and women with HIV-1 viral load \<200 copies/mL on stable ART and 25(OH)D level ≥30ng/mL receive no intervention.

Vitamin D Insufficient

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Vitamin D