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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University Hospital Case Medical Center
Sponsor:
Collaborator:
Emory-Children's Center
Information provided by (Responsible Party):
Grace McComsey, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01410305
First received: August 4, 2011
Last updated: July 17, 2014
Last verified: June 2013

August 4, 2011
July 17, 2014
September 2011
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01410305 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Vit D and HIV-Cardiovascular Disease in Children and Young Adults Vitamin D and HIV-CVD in Children and Young Adults
Vitamin D Metabolism Inflammation, and Cardiovascular Risk in HIV-infected Children and Young Adults

The relationship of Vitamin D levels in children and young adults to atherosclerosis.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

plasma, serum, PBMCs, urine

Non-Probability Sample

Any HIV+ patient between the ages of 8 and 25 and matched HIV- controls matched by age and race.

Vitamin D Deficiency
Not Provided
  • HIV+
    HIV Positive children or young people between the ages of 8 and 25
  • HIV Negative
    HIV Negative matched controls by age and race
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
8 Years to 25 Years
Yes
Contact: Norma Storer, RN 216-844-2752 storer.norma@clevelandactu.org
Contact: Allison R Eckard, MD 404-616-2213 allison.ross.eckard@emory.edu
United States
 
NCT01410305
1Ro1HD070490-01
No
Grace McComsey, University Hospitals of Cleveland
University Hospital Case Medical Center
Emory-Children's Center
Principal Investigator: Grace McComsey, MD University Hospital Case Medical Center
Principal Investigator: Allison Ross Eckard, MD Emory-Children's Center
University Hospital Case Medical Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP