Clinical trial NCT00911664: Vitamin D Supplementation and CD4 Count in HIV-Infected Children
Official title: Vitamin D Supplementation and CD4 Count in HIV-Infected Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
Keywords: Vitamin D
HIV-Infected children
CD4 count
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2009-06-02
Enrollment: 54
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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?

Eligibility criteria: 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

Primary outcomes:
measure: Change in CD4 percent associated with vitamin D supplementation in HIV-infected children
timeFrame: 6 months
Secondary outcomes:
measure: Correlation of the actual 25(OH)D and 1,25(OH)D serum levels with CD4 percent
timeFrame: 6 months
measure: Change in absolute CD4 count with vitamin D supplementation
timeFrame: 6 months
measure: Change in HIV viral load with vitamin D supplementation
timeFrame: 6 months
measure: Other measures of vitamin D metabolism including serum calcium, phosphate, alkaline phosphatase, parathyroid hormone (PTH), and urinary calcium/creatinine ratio
timeFrame: 0, 3 and 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Ari Bitnun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.