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Vitamin D Dose Finding Study

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ClinicalTrials.gov Identifier: NCT01092338
Recruitment Status : Completed
First Posted : March 24, 2010
Results First Posted : September 18, 2013
Last Update Posted : September 18, 2013
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
AIDS
Intervention: Drug: Cholecalciferol (Vit D3)

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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.


  More Information

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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01092338     History of Changes
Other Study ID Numbers: 09-007332
R01AT005531 ( U.S. NIH Grant/Contract )
First Submitted: March 23, 2010
First Posted: March 24, 2010
Results First Submitted: January 7, 2013
Results First Posted: September 18, 2013
Last Update Posted: September 18, 2013