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
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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.
No text entered.

Reporting Groups
  Description
4000IU/d of Vitamin D3 No text entered.
7000IU/d Vitamin D3 No text entered.
Total Total of all reporting groups

Baseline Measures
    4000IU/d of Vitamin D3     7000IU/d Vitamin D3     Total  
Number of Participants  
[units: participants]
  22     22     44  
Age  
[units: participants]
     
<=18 years     9     7     16  
Between 18 and 65 years     13     15     28  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  18.4  ± 4.5     19.1  ± 5.0     18.7  ± 4.7  
Gender  
[units: participants]
     
Female     7     7     14  
Male     15     15     30  
Region of Enrollment  
[units: participants]
     
United States     22     22     44  



  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


  More Information