Vitamin D Supplementation in HIV Youth

University Hospitals (UH)

Status and phase: Completed; Phase 3; Phase 2

Conditions: HIV Infections

Treatments: Drug: Vitamin D supplementation-; Drug: Vitamin D control dose

Study type: Interventional

Funder types: Other

Identifiers

NCT01523496

09-11-06

Details and patient eligibility

About

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

Full description

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.

Enrollment: 190 patients

Sex: All

Ages: 8 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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190 participants in 2 patient groups

HIV + Young Adults

Active Comparator group

Description:

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)

Treatment:

Drug: Vitamin D control dose

Drug: Vitamin D supplementation-

HIV - Controls

Active Comparator group

Description:

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)

Treatment:

Drug: Vitamin D control dose

Drug: Vitamin D supplementation-