Status:
COMPLETED
Vitamin D Supplementation in HIV Youth
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Emory University
Conditions:
HIV Infections
Eligibility:
All Genders
8-25 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine the correct dose of Vitamin D to give to prevent HIV related complications.
Detailed 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-relate...
Eligibility Criteria
Inclusion
- 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
- \> 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT01523496
Start Date
December 1 2011
End Date
August 1 2016
Last Update
March 8 2018
Active Locations (2)
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1
Emory Children's Center
Atlanta, Georgia, United States, 30322
2
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106