Vitamin D Supplementation and CD4 Count in HIV-Infected Children

Study Overview
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Brief Summary
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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
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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: Does vitamin D supplementation lead to a change in CD4 percent (CD4 count) in HIV-infected children? 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?

Official Title
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Vitamin D Supplementation and CD4 Count in HIV-Infected Children

Conditions
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HIV

Intervention / Treatment
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* Dietary Supplement: Vitamin D
* Drug: No supplementation
* Dietary Supplement: Vitamin D


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: No supplementation<br>* Control<br>|
| Experimental: 2<br> | Dietary Supplement: Vitamin D<br>* Weekly dose of 5600 IU (800 IU per day)<br>|
| Experimental: 3<br> | Dietary Supplement: Vitamin D<br>* Weekly dose of 11,200 IU (1600 IU per day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CD4 percent associated with vitamin D supplementation in HIV-infected children |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, HIV-Infected children, CD4 count