Vitamin D Dose Finding Study

This study has been completed.
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia Identifier:
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
Intervention: Drug: Cholecalciferol (Vit D3)

  Participant Flow

  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
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  
[units: participants]
<=18 years     9     7     16  
Between 18 and 65 years     13     15     28  
>=65 years     0     0     0  
[units: years]
Mean (Standard Deviation)
  18.4  (4.5)     19.1  (5.0)     18.7  (4.7)  
[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
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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

Publications of Results:

Responsible Party: Children's Hospital of Philadelphia 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