Vitamin D in HIV-Infected Patients on HAART

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jordan E. Lake M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01250899
First received: November 30, 2010
Last updated: August 25, 2014
Last verified: August 2014

November 30, 2010
August 25, 2014
October 2010
June 2012   (final data collection date for primary outcome measure)
Success Rate of a Standard, 12-week, Vitamin D Supplementation Regimen in Achieving a 25(OH) D Levels>30ng/mL in Virologically-suppressed, Vitamin D-depleted, HIV-infected Subjects [ Time Frame: June 2012 ] [ Designated as safety issue: No ]
Percent participants successfully repleted to 25(OH)D >= 30 ng/mL after 12 weeks.
To assess the success rate of a standard, 12-week, vitamin D supplementation regimen in achieving a 25(OH) D levels>30ng/mL in virologically-suppressed, vitamin D-depleted, HIV-infected subjects [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01250899 on ClinicalTrials.gov Archive Site
Not Provided
To assess changes in levels of fasting glucose, insulin, and insulin resistance (as measured by HOMA-IR) following vitamin D supplementation in virologically-suppressed, HIV-infected subjects with baseline 25(OH) D levels<30ng/mL [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Vitamin D in HIV-Infected Patients on HAART
Vitamin D, Immune Activation, and Metabolic Abnormalities in HIV-Infected Patients on Antiretroviral Therapy

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Vitamin D Deficiency
  • HIV
Dietary Supplement: 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.
  • No Intervention: Vitamin D sufficient
    HIV-infected men and women with HIV-1 viral load<200 copies/mL on stable ART and 25OHD level >=30ng/mL gets no intervention.
  • Experimental: Vitamin D insufficient
    HIV-infected men and women with HIV-1 viral load<200 copies /mL on stable ART and 25 OHD level <30ng/mL get 50000 IU twice weekly for 5 weeks followed by 2000 IU daily to complete 12 weeks.
    Intervention: Dietary Supplement: Vitamin D
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
June 2012
June 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01250899
CARE Vitamin D
No
Jordan E. Lake M.D., University of California, Los Angeles
University of California, Los Angeles
Not Provided
Study Director: Judith Currier, M.D. UCLA CARE Center
Principal Investigator: Jordan Lake, M.D. UCLA CARE Center
University of California, Los Angeles
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP