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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
Results First Received: August 25, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Vitamin D Sufficient HIV-infected men and women on stable ART underwent routine serum 25(OH)D screening. Persons with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D ≥30ng/mL had a baseline visit only, and did not receive vitamin D supplementation.
Vitamin D Insufficient HIV-infected men and women on stable ART underwent routine serum 25(OH)D screening. Persons with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D <30ng/mL received open-label, oral vitamin D3 50,000 IU twice weekly for 5 weeks, then 2000 IU daily to complete 12 weeks. Serum 25(OH)D levels were measured at baseline, 12 weeks and 24 weeks.

Participant Flow:   Overall Study
    Vitamin D Sufficient   Vitamin D Insufficient
STARTED   40   82 
COMPLETED   40   82 
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 on stable ART with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D ≥30ng/mL had a baseline visit only, and did not receive vitamin D supplementation.
Vitamin D Insufficient HIV-infected men and women on stable ART with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D <30ng/mL received open-label, oral vitamin D3 50,000 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 
Overall Participants Analyzed 
[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 in Achieving a 25(OH)D Level ≥30ng/mL After 12 Weeks of Oral Vitamin D Supplementation.   [ Time Frame: 12 weeks ]


  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
This trial was prospective, but open label and not randomized. However, randomization to placebo would not have been clinically appropriate.


  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



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: November 24, 2014