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Vitamin D and HIV-Cardiovascular Disease in Children and Young Adults

This study has been completed.
Emory-Children's Center
Information provided by (Responsible Party):
Grace McComsey, University Hospital Case Medical Center Identifier:
First received: August 4, 2011
Last updated: June 24, 2016
Last verified: June 2016
The relationship of Vitamin D levels in children and young adults to atherosclerosis.

Vitamin D Deficiency

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Vitamin D Metabolism Inflammation, and Cardiovascular Risk in HIV-infected Children and Young Adults

Resource links provided by NLM:

Further study details as provided by University Hospitals Cleveland Medical Center:

Primary Outcome Measures:
  • Vitamin D levels [ Time Frame: One time point at entry ] [ Designated as safety issue: No ]
    To perform a cross-sectional analysis of blood vitamin D status among the HIV-infected children and young adults to evaluated the point prevalence fo plasma 25(OH)D levels indicating vitamin D insufficiency, deficiency and severe deficiency, and to compare the prevalence to a matched uninfected healthy control group.

Biospecimen Retention:   Samples With DNA
plasma, serum, PBMCs, urine

Enrollment: 290
Study Start Date: September 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
HIV Positive children or young people between the ages of 8 and 25
HIV Negative
HIV Negative matched controls by age and race


Ages Eligible for Study:   8 Years to 25 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Any HIV+ patient between the ages of 8 and 25 and matched HIV- controls matched by age and race.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01410305

United States, Georgia
Emory Chldren's Center
Atlanta, Georgia, United States, 30308
United States, Ohio
University Hospitals Case Medical Center, Case Western Reserve University
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Emory-Children's Center
Principal Investigator: Grace McComsey, MD University Hospitals Cleveland Medical Center
Principal Investigator: Allison Ross Eckard, MD Emory-Children's Center
  More Information

Responsible Party: Grace McComsey, Professor of Pediatrics and Medicine, University Hospital Case Medical Center Identifier: NCT01410305     History of Changes
Other Study ID Numbers: 1R01HD070490-01 
Study First Received: August 4, 2011
Last Updated: June 24, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University Hospitals Cleveland Medical Center:
Vitamin D Deficiency
HIV+ Children
HIV+ Young Adults

Additional relevant MeSH terms:
Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on October 21, 2016