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

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.
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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

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

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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