Status:
COMPLETED
Vitamin D and HIV-Cardiovascular Disease in Children and Young Adults
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Emory-Children's Center
Conditions:
Vitamin D Deficiency
Eligibility:
All Genders
8-25 years
Brief Summary
The relationship of Vitamin D levels in children and young adults to atherosclerosis.
Eligibility Criteria
Inclusion
- Inclusion Criteria - Documentation of HIV Infection Between ages of 8 and 25
- On stable ART for at least 12 weeks for the HIV+ patients
- Cumulative duration of ART for at least 48 weeks for HIV + patients
- Healthy child/young adult with age and race matched to HIV+ patient for the HIV- controls
- Absence of HIV based on medical and medication history
- Exclusion Criteria:
- Taking \> 800 IU of Vitamin D per day
- Parathyroid or Calcium disorders
- Acute illness and active inflammatory condition
- Chronic illnesses that include malignancy, diabetes, CAD
- Pregnancy and lactation
- Creatinine Clearance \<50 ml/min
- Hgb \< 9.0 g/dL
- AST and ALT \> 2.5 upper limits of normal
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT01410305
Start Date
September 1 2011
End Date
December 1 2014
Last Update
June 28 2016
Active Locations (2)
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1
Emory Chldren's Center
Atlanta, Georgia, United States, 30308
2
University Hospitals Case Medical Center, Case Western Reserve University
Cleveland, Ohio, United States, 44106