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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: November 24, 2014
Last verified: November 2014
  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: Parallel 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:


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

Primary Outcome Measures:
  • Success Rate in Achieving a 25(OH)D Level ≥30ng/mL After 12 Weeks of Oral Vitamin D Supplementation. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Percentage of participants successfully repleted to 25(OH)D ≥30ng/mL after 12 weeks of oral vitamin D supplementation.


Enrollment: 122
Study Start Date: October 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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
Study First Received: November 30, 2010
Results First Received: August 25, 2014
Last Updated: November 24, 2014
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
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014