Vitamin D Supplementation and CD4 Count in HIV-Infected Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by The Hospital for Sick Children.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00911664
First received: May 29, 2009
Last updated: November 11, 2009
Last verified: November 2009

May 29, 2009
November 11, 2009
February 2009
December 2009   (final data collection date for primary outcome measure)
Change in CD4 percent associated with vitamin D supplementation in HIV-infected children [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00911664 on ClinicalTrials.gov Archive Site
  • Correlation of the actual 25(OH)D and 1,25(OH)D serum levels with CD4 percent [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in absolute CD4 count with vitamin D supplementation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in HIV viral load with vitamin D supplementation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Other measures of vitamin D metabolism including serum calcium, phosphate, alkaline phosphatase, parathyroid hormone (PTH), and urinary calcium/creatinine ratio [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Vitamin D Supplementation and CD4 Count in HIV-Infected Children
Vitamin D Supplementation and CD4 Count in HIV-Infected Children

To find out if vitamin D supplementing can lead to an improvement in immunological status in HIV-infected children as part of routine clinical care

The objective of this study is to determine the impact of vitamin D on immunological status in HIV-infected children as measured by CD4 count (CD4 percent). We will determine if vitamin D supplementation leads to a measurable change in CD4 count (CD4 percent) in HIV-infected children in the context of routine clinical care.

Specific study questions are:

  1. Does vitamin D supplementation lead to a change in CD4 percent (CD4 count) in HIV-infected children?
  2. Do the serum levels of the active form of vitamin D [1, 25(OH)2D and 25(OH)D] correlate with CD4 percent (CD4 count) in HIV-infected children?
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
HIV
  • Dietary Supplement: Vitamin D
    Weekly dose of 5600 IU (800 IU per day)
  • Drug: No supplementation
    Control
  • Dietary Supplement: Vitamin D
    Weekly dose of 11,200 IU (1600 IU per day)
  • Placebo Comparator: 1
    Intervention: Drug: No supplementation
  • Experimental: 2
    Intervention: Dietary Supplement: Vitamin D
  • Experimental: 3
    Intervention: Dietary Supplement: Vitamin D
Kakalia S, Sochett EB, Stephens D, Assor E, Read SE, Bitnun A. Vitamin D supplementation and CD4 count in children infected with human immunodeficiency virus. J Pediatr. 2011 Dec;159(6):951-7. doi: 10.1016/j.jpeds.2011.06.010. Epub 2011 Aug 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
54
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-infected children as defined by ≥ 2 positive HIV DNA PCRs and/or HIV cultures of blood for children less than 18 months of age, or by positive screening and confirmatory serologic testing in those older than 18 months of age
  • Stable HIV disease, defined by the absence of change in HIV clinical or immunologic category during the preceding 6 month period, prior to commencing the study
  • Age 3 years through 18 years
  • Voluntary informed consent

Exclusion Criteria:

  • Any antiretroviral medication change in the 6 months prior to the study, or any anticipated antiretroviral medication change during the duration of the study
  • Active participation in another treatment trial
  • Serum calcium < 2mmol/L at baseline
Both
1 Year to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00911664
1000012867
No
Ari Bitnun, The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Ari Bitnun, MD The Hospital for Sick Children
The Hospital for Sick Children
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP