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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | Weekly dose of 5600 IU (800 IU per day) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CD4 percent associated with vitamin D supplementation in HIV-infected children | 6 months |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ari Bitnun, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21820130 | Derived | 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. |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| No supplementation |
| Drug |
Control |
|
| Vitamin D | Dietary Supplement | Weekly dose of 11,200 IU (1600 IU per day) |
|
| 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 |