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Vitamin D Supplements for HIV-positive Patients on cART

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Andrea Branch, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT01295034
First received: February 10, 2011
Last updated: March 6, 2017
Last verified: March 2017
Results First Received: March 6, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Condition: HIV-associated Co-morbidities
Interventions: Dietary Supplement: conventional vitamin D treatment
Drug: tiered/titrated vitamin D dosing

  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
Conventional Vitamin D Treatment conventional vitamin D treatment: Subjects in Protocol A (the conventional/active placebo arm) received 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
Tiered/Titrated Vitamin D Dosing tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.

Participant Flow:   Overall Study
    Conventional Vitamin D Treatment   Tiered/Titrated Vitamin D Dosing
STARTED   32   30 
COMPLETED   27   25 
NOT COMPLETED   5   5 
Lost to Follow-up                5                5 



  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.
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Reporting Groups
  Description
Conventional Vitamin B Dosing Subjects in Protocol A (the conventional/active placebo arm) will receive 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
Tiered/Titrated Vitamin B Dosing tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
Total Total of all reporting groups

Baseline Measures
   Conventional Vitamin B Dosing   Tiered/Titrated Vitamin B Dosing   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   30   62 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      32 100.0%      30 100.0%      62 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 47 
 (39 to 51) 
 48 
 (42 to 52) 
 48 
 (41 to 51) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      7  21.9%      6  20.0%      13  21.0% 
Male      25  78.1%      24  80.0%      49  79.0% 
Region of Enrollment 
[Units: Participants]
     
United States   32   30   62 


  Outcome Measures
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1.  Primary:   25(OH)D Levels   [ Time Frame: baseline and 12 months ]

2.  Secondary:   CD4+T Cell Count   [ Time Frame: baseline and 12 months ]


  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: Andrea D. Branch PhD
Organization: Icahn School of Medicine at Mount Sinai
phone: 212 659 8371
e-mail: andrea.branch@mssm.edu


Publications:

Responsible Party: Andrea Branch, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01295034     History of Changes
Other Study ID Numbers: GCO 10-0679
R01DA031095 ( US NIH Grant/Contract Award Number )
Study First Received: February 10, 2011
Results First Received: March 6, 2017
Last Updated: March 6, 2017