Vitamin D Supplementation in HIV Youth

Study Overview
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Brief Summary
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The purpose of this study is to determine the correct dose of Vitamin D to give to prevent HIV related complications.

Detailed Description
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The purpose of the this study was to compare control dose of vitamin D (low dose of 600 IU/d) to supplementation dose (medium dose of 2000 IU/d or higher doses of vitamin D of 4000 IU/d) on HIV-related comorbidities including immune activation, inflammation, cardiovascular diseases, and metabolic complications in HIV-infected youth.

Official Title
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Vitamin D Supplementation and HIV-related Complications in Children and Young Adults

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Vitamin D control dose
* Drug: Vitamin D supplementation-


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 8-25 Documented HIV-1 infection On stable antiretroviral therapy for > 3 months Cumulative antiretroviral therapy of at least 6 months 25(OH)D level < 30 ng/ml at screening Exclusion Criteria: > 400 IU daily regular vitamin D intake Parathyroid/calcium disorders Active malignancy Pregnancy/intent to become pregnant/breastfeeding Chronic infectious/inflammatory conditions Creatinine clearance < 50 ml/min Hemoglobin < 9.0 g/dL Aspartate aminotransferase and alanine aminotransferase > 2.5 upper limit of normal Diabetes requiring hypoglycemic agents Known coronary artery disease Inability to swallow pills

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HIV + Young Adults<br>All will be HIV+ and receiving randomized dose of vitamin D control dose (low dose) or supplementation dose (vitamin D medium dose or vitamin D high dose) | Drug: Vitamin D control dose<br>* 18,000 IU per month<br>* Other names: 25(OH)D3 low dose;Drug: Vitamin D supplementation-<br>* 60,000 IU per month(medium dose) or 120,000 IU/month(high dose)<br>* Other names: 25(OH)D3 medium dose or 25(OH)high dose;|
| Active Comparator: HIV - Controls<br>HIV negative controls will be receiving randomized Vitamin D doses: control vitamin D dose (low dose) or vitamin D supplementation dose (vitamin D medium dose or vitamin D high dose) | Drug: Vitamin D control dose<br>* 18,000 IU per month<br>* Other names: 25(OH)D3 low dose;Drug: Vitamin D supplementation-<br>* 60,000 IU per month(medium dose) or 120,000 IU/month(high dose)<br>* Other names: 25(OH)D3 medium dose or 25(OH)high dose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Serum 25(OH)D3 Levels | Evaluate the dose-related efficacy of correction of Vitamin D deficiency for 25(OH)D3 levels in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral Vitamin D supplementation: control dose (18,000 IU per month) or supplemented dose (medium 60,000IU per month or high dose 120,000IU/month ) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Vitamin D Binding Protein (VDBP) | Evaluate the dose-related efficacy of vitamin D binding Protein in levels in the blood in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral vitamin D supplementation. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Vitamin D Deficiency