Vitamin D Supplementation in HIV Youth

University Hospitals Cleveland Medical Center190 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

190

Conditions

HIV Infections

Interventions

Vitamin D control doseDRUG

18,000 IU per month

Vitamin D supplementation-DRUG

60,000 IU per month(medium dose) or 120,000 IU/month(high dose)

Eligibility

Sex: ALLMin age: 8 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Emory Children's Center

Atlanta, Georgia, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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 )

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 6 months

Data from ClinicalTrials.gov

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