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 ]

Measure Type Primary
Measure Title Safety
Measure Description Determined by incidence of elevated serum calcium (above age specific range) associated with elevated serum 25D concentrations (>160ng/ml).
Time Frame 12 weeks  
Safety Issue Yes  

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.
Number of subjects with elevated serum calcium (above age specific range) associated with elevated serum 25D concentrations (>160ng/ml)

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

Measured Values
    4000IU/d of Vitamin D3     7000IU/d Vitamin D3  
Number of Participants Analyzed  
[units: participants]
  22     22  
Safety  
[units: participants]
  0     0  

No statistical analysis provided for Safety



2.  Primary:   Efficacy of the Two Doses (4000 and 7000 IU/d)   [ Time Frame: 12 weeks ]

Measure Type Primary
Measure Title Efficacy of the Two Doses (4000 and 7000 IU/d)
Measure Description Daily D3 supplementation will result in 25D >= to 32/ng/ml
Time Frame 12 weeks  
Safety Issue No  

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.
Number of subjects with serum 25D concentration levels >= 32 ng/ml after 12 weeks of supplementation.

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

Measured Values
    4000IU/d of Vitamin D3     7000IU/d Vitamin D3  
Number of Participants Analyzed  
[units: participants]
  22     22  
Efficacy of the Two Doses (4000 and 7000 IU/d)  
[units: participants]
  16     19  

No statistical analysis provided for Efficacy of the Two Doses (4000 and 7000 IU/d)




  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: Virginia Stallings
Organization: Children's Hospital of Philadephia
phone: 215-590-1664
e-mail: stallingsv@email.chop.edu


Publications of Results:

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01092338     History of Changes
Other Study ID Numbers: 09-007332, R01AT005531
Study First Received: March 23, 2010
Results First Received: January 7, 2013
Last Updated: August 1, 2013
Health Authority: United States: Institutional Review Board