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
Results First Received: August 25, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Vitamin D Deficiency
HIV
Intervention: Dietary Supplement: Vitamin D

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Vitamin D Insuffcient HIV-infected men and women with HIV-1 RNA<200 copies/mL on stable ART and daily vitamin D< 4000IU were enrolled. Subjects with low 25(OH)D took 50,000IU vitamin D3 twice weekly for 5 weeks then 2000IU daily to complete 12 weeks.
Vitamin D Sufficient HIV-infected men and women with HIV-1 RNA<200 copies/mL on stable ART and daily vitamin D< 4000IU were enrolled. If 25 OHDlevel >=30 ng/mL participants had baseline visit only.

Participant Flow:   Overall Study
    Vitamin D Insuffcient     Vitamin D Sufficient  
STARTED     82     40  
COMPLETED     82     40  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV-infected men and women with HIV-1 RNA <200 copies/mL on stable ART and daily vitamin D <400IU were enrolled

Reporting Groups
  Description
Vitamin D Sufficient HIV-infected men and women with HIV-1 RNA<200 copies/mL on stable ART and daily vitamin D< 4000IU were enrolled. Subjects with normal 25(OH)D only had baseline visit.
Vitamin D Insufficient HIV-infected men and women with HIV-1 RNA<200 copies/mL on stable ART and daily vitamin D< 4000IU were enrolled. Subjects with low 25(OH)D took 50000 IU twice weekly for 5 weeks, then 2000 IU daily to complete 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Vitamin D Sufficient     Vitamin D Insufficient     Total  
Number of Participants  
[units: participants]
  40     82     122  
Age  
[units: years]
Median ( Inter-Quartile Range )
  49  
  ( 43 to 56 )  
  48  
  ( 39 to 57 )  
  48  
  ( 39 to 57 )  
Gender  
[units: participants]
     
Female     2     4     6  
Male     38     78     116  



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Jordan Lake
Organization: University of California, Los Angeles
phone: 310-557-2273
e-mail: jlake@mednet.ucla.edu


No publications provided


Responsible Party: Jordan E. Lake 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: August 25, 2014
Health Authority: United States: Institutional Review Board