Vitamin D Supplementation in HIV Youth

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Collaborator: Emory University
• Treatments: Calcifediol; Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

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