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

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ClinicalTrials.gov Identifier: NCT01410305
Recruitment Status : Completed
First Posted : August 5, 2011
Last Update Posted : June 28, 2016
Sponsor:
Collaborator:
Emory-Children's Center
Information provided by (Responsible Party):
Grace McComsey, University Hospital Case Medical Center

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The relationship of Vitamin D levels in children and young adults to atherosclerosis.

Condition or disease
Vitamin D Deficiency

Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 290 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Vitamin D Metabolism Inflammation, and Cardiovascular Risk in HIV-infected Children and Young Adults
Study Start Date : September 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
HIV+
HIV Positive children or young people between the ages of 8 and 25
HIV Negative
HIV Negative matched controls by age and race


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Vitamin D levels [ Time Frame: One time point at entry ]
    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

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   8 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410305


Locations
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
Investigators
Principal Investigator: Grace McComsey, MD University Hospitals Cleveland Medical Center
Principal Investigator: Allison Ross Eckard, MD Emory-Children's Center
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Grace McComsey, Professor of Pediatrics and Medicine, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT01410305     History of Changes
Other Study ID Numbers: 1R01HD070490-01 ( U.S. NIH Grant/Contract )
First Posted: August 5, 2011    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016

Keywords provided by Grace McComsey, University Hospital Case Medical Center:
Vitamin D Deficiency
HIV+ Children
HIV+ Young Adults

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