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Vitamin D in HIV-Infected Patients on HAART

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01250899
First received: November 30, 2010
Last updated: August 17, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention
Vitamin D Deficiency
HIV
 Dietary Supplement: Vitamin D

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vitamin D, Immune Activation, and Metabolic Abnormalities in HIV-Infected Patients on Antiretroviral Therapy

Resource links provided by NLM:

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

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 140
Study Start Date: October 2010
Estimated Study Completion Date: January 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250899

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

No publications provided

Responsible Party: Jordan Lake, M.D., UCLA CARE Center
ClinicalTrials.gov Identifier: NCT01250899     History of Changes
Other Study ID Numbers: CARE Vitamin D
Study First Received: November 30, 2010
Last Updated: August 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
HIV
Vitamin D
HAART

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
 Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013