Vitamin D Dose Finding Study

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01092338
First received: March 23, 2010
Last updated: August 1, 2013
Last verified: August 2013
Results First Received: January 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
AIDS
Intervention: Drug: Cholecalciferol (Vit D3)

  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
The Study started enrollment in 01/2010 and completed in 01/2011. A total of 44 subjects were enrolled including 19 with perinatally-acquired HIV/AIDS (PA) and 25 with behaviorally-acquired HIV/AIDS (BA).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects taking a vitamin D supplement or multi-vitamin were eligible if they were willing to discontinue supplementation after a minimum of a 2 month washout period.

Reporting Groups
  Description
4000IU/d of Vitamin D3 No text entered.
7000IU/d Vitamin D3 No text entered.

Participant Flow:   Overall Study
    4000IU/d of Vitamin D3     7000IU/d Vitamin D3  
STARTED     22     22  
COMPLETED     21     21  
NOT COMPLETED     1     1  



  Baseline Characteristics


  Outcome Measures
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1.  Primary:   Safety   [ Time Frame: 12 weeks ]

2.  Primary:   Efficacy of the Two Doses (4000 and 7000 IU/d)   [ 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
No text entered.


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