Vitamin D and HIV-Cardiovascular Disease in Children and Young Adults
NCT ID: NCT01410305
Last Updated: 2016-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
290 participants
OBSERVATIONAL
2011-09-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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HIV+
HIV Positive children or young people between the ages of 8 and 25
No interventions assigned to this group
HIV Negative
HIV Negative matched controls by age and race
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
8 Years
25 Years
ALL
Yes
Sponsors
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Emory-Children's Center
OTHER
University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Grace McComsey
Professor of Pediatrics and Medicine
Principal Investigators
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Grace McComsey, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Allison Ross Eckard, MD
Role: PRINCIPAL_INVESTIGATOR
Emory-Children's Center
Locations
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Emory Chldren's Center
Atlanta, Georgia, United States
University Hospitals Case Medical Center, Case Western Reserve University
Cleveland, Ohio, United States
Countries
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Other Identifiers
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