Vitamin D in HIV-Infected Patients on HAART

NCT01250899 | Completed Results

• 1 other identifier: CARE Vitamin D
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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

Keywords

HIV; Vitamin D; HAART

Outcome Measures

Primary Outcomes (1)

• Success Rate in Achieving a 25(OH)D Level ≥30ng/mL After 12 Weeks of Oral Vitamin D Supplementation.

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

  12 weeks

Study Arms (2)

Vitamin D Sufficient

NO INTERVENTION

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

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.

Dietary Supplement: Vitamin D

Interventions

Vitamin D 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.

Vitamin D Insufficient

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA CARE Center

Los Angeles, California, 90035, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

This trial was prospective, but open label and not randomized. However, randomization to placebo would not have been clinically appropriate.

Results Point of Contact

• Title: Dr Jordan Lake
• Organization: University of California, Los Angeles

jlake@mednet.ucla.edu

310-557-2273

Study Officials

• Judith Currier, M.D.

  University of California, Los Angeles

  STUDY DIRECTOR

• Jordan Lake, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 1, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 25, 2014
• Results First Posted: September 5, 2014

Record last verified: 2014-11

Locations

US (1)