Vitamin D in HIV-Infected Patients on HAART

NCT ID: NCT01250899

Last Updated: 2014-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-06-30

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.

Conditions

Vitamin D Deficiency; HIV

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vitamin D Sufficient

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Vitamin D Insufficient

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.

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

50,000 IU vitamin D3 twice weekly for 5 weeks, followed by 2000 IU daily maintenance supplementation to complete 12 weeks. At the end of the 12-week period, 25(OH)D levels will be checked. If the subject is still deficient, he/she may undergo a second period of supplementation (at the discretion of their provider) to complete a total of 24 weeks. After 24 weeks, we anticipate all subjects will be kept on daily maintenance supplementation by their primary physicians.

Interventions

Vitamin D

50,000 IU vitamin D3 twice weekly for 5 weeks, followed by 2000 IU daily maintenance supplementation to complete 12 weeks. At the end of the 12-week period, 25(OH)D levels will be checked. If the subject is still deficient, he/she may undergo a second period of supplementation (at the discretion of their provider) to complete a total of 24 weeks. After 24 weeks, we anticipate all subjects will be kept on daily maintenance supplementation by their primary physicians.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Jordan E. Lake M.D.

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Judith Currier, M.D.

Role: STUDY_DIRECTOR

University of California, Los Angeles

Jordan Lake, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA CARE Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

CARE Vitamin D

Identifier Type: -

Identifier Source: org_study_id