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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
  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 Hospital Case 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


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
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 ClinicalTrials.gov identifier: NCT01410305

Contacts
Contact: Norma Storer, RN 216-844-2752 storer.norma@clevelandactu.org
Contact: Allison R Eckard, MD 404-616-2213 allison.ross.eckard@emory.edu

Locations
United States, Georgia
Emory Chldren's Center Active, not recruiting
Atlanta, Georgia, United States, 30308
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 Hospital Case Medical Center
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: July 17, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University Hospital Case Medical Center:
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
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014