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Vitamin D in HIV-Infected Patients on HAART

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01250899
Recruitment Status : Completed
First Posted : December 1, 2010
Results First Posted : September 5, 2014
Last Update Posted : November 25, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Vitamin D Deficiency HIV Dietary Supplement: Vitamin D

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vitamin D, Immune Activation, and Metabolic Abnormalities in HIV-Infected Patients on Antiretroviral Therapy
Study Start Date : October 2010
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: 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.
Experimental: 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.
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.

Outcome Measures

Primary Outcome Measures :
  1. Success Rate in Achieving a 25(OH)D Level ≥30ng/mL After 12 Weeks of Oral Vitamin D Supplementation. [ Time Frame: 12 weeks ]
    Percentage of participants successfully repleted to 25(OH)D ≥30ng/mL after 12 weeks of oral vitamin D supplementation.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01250899

United States, California
Los Angeles, California, United States, 90035
Sponsors and Collaborators
University of California, Los Angeles
Study Director: Judith Currier, M.D. University of California, Los Angeles
Principal Investigator: Jordan Lake, M.D. University of California, Los Angeles
More Information

Responsible Party: Jordan E. Lake M.D., M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01250899     History of Changes
Other Study ID Numbers: CARE Vitamin D
First Posted: December 1, 2010    Key Record Dates
Results First Posted: September 5, 2014
Last Update Posted: November 25, 2014
Last Verified: November 2014

Keywords provided by Jordan E. Lake M.D., University of California, Los Angeles:
Vitamin D

Additional relevant MeSH terms:
Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents