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.
Verified June 2013 by University Hospitals of Cleveland
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: January 14, 2014
Last verified: June 2013
  Purpose

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


Condition
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 of Cleveland:

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


Estimated Enrollment: 300
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV+
HIV Positive children or young people between the ages of 8 and 25
HIV Negative
HIV Negative matched controls by age and race

  Eligibility

Ages Eligible for Study:   8 Years to 25 Years
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410305

Contacts
Contact: Norma Storer, RN 216-844-2752 storer.norma@clevelandactu.org
Contact: Zoa Hepbourn 404-616-2213 nmcglos@emory.edu

Locations
United States, Georgia
Emory Chldren's Center Recruiting
Atlanta, Georgia, United States, 30308
Contact: Zoa Hepburn    404-616-2213    zoa.hepburn@emory.edu   
Contact: Allison Ross Eckard, MD    404-727-8224    a.ross.eckard@emory.edu   
Principal Investigator: Allison R Eckard, MD         
United States, Ohio
University Hospitals Case Medical Center, Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Norma Storer, RN    216-844-2752    storer.norma@clevelandactu.org   
Contact: Danielle Labbato, RN    216-844-2739      
Principal Investigator: Grace McComsey, MD         
Sponsors and Collaborators
University Hospitals of Cleveland
Emory-Children's Center
Investigators
Principal Investigator: Grace McComsey, MD University Hospital Case Medical Center
Principal Investigator: Allison Ross Eckard, MD Emory-Children's Center
  More Information

No publications provided

Responsible Party: Grace McComsey, Professor of Pediatrics and Medicine, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01410305     History of Changes
Other Study ID Numbers: 1Ro1HD070490-01
Study First Received: August 4, 2011
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 20, 2014