Back to resultsVitamin D in HIV-Infected Patients on HAART
Primary Purpose
Vitamin D Deficiency, HIV
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency focused on measuring HIV, Vitamin D, HAART
Eligibility 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).
Sites / Locations
- UCLA CARE Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Vitamin D Sufficient
Vitamin D Insufficient
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01250899
First Posted
November 30, 2010
Last Updated
November 24, 2014
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT01250899
Brief Title
Vitamin D in HIV-Infected Patients on HAART
Official Title
Vitamin D, Immune Activation, and Metabolic Abnormalities in HIV-Infected Patients on Antiretroviral Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, HIV
Keywords
HIV, Vitamin D, HAART
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D Sufficient
Arm Type
No Intervention
Arm Description
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.
Arm Title
Vitamin D Insufficient
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
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.
Primary Outcome Measure Information:
Title
Success Rate in Achieving a 25(OH)D Level ≥30ng/mL After 12 Weeks of Oral Vitamin D Supplementation.
Description
Percentage of participants successfully repleted to 25(OH)D ≥30ng/mL after 12 weeks of oral vitamin D supplementation.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Currier, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jordan Lake, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA CARE Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90035
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Vitamin D in HIV-Infected Patients on HAART
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