HIV
Conditions
Keywords
Vitamin D, HIV-Infected children, CD4 count
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?
Interventions
DIETARY_SUPPLEMENTVitamin D
Weekly dose of 5600 IU (800 IU per day)
Control
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in CD4 percent associated with vitamin D supplementation in HIV-infected children | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of the actual 25(OH)D and 1,25(OH)D serum levels with CD4 percent | 6 months |
| Change in absolute CD4 count with vitamin D supplementation | 6 months |
| Change in HIV viral load with vitamin D supplementation | 6 months |
| Other measures of vitamin D metabolism including serum calcium, phosphate, alkaline phosphatase, parathyroid hormone (PTH), and urinary calcium/creatinine ratio | 0, 3 and 6 months |
Countries
Canada
Outcome results
None listed