Vitamin D Supplementation in HIV Youth

Completed · Phase 2/Phase 3

Conditions studied: HIV Infections

In brief

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

Key facts

Study ID

NCT01523496

Run by

University Hospitals Cleveland Medical Center

People needed

190

Starts

2011-12-01

Expected to finish

2016-08-01

Last updated by the study team

2018-03-08

Who can join

Age: 8 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• > 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

Where it is running

• Emory Children's Center — Atlanta, Georgia, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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