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

This study has been completed.

Sponsor:

Collaborator:

Emory-Children's Center

Information provided by (Responsible Party):

Grace McComsey, University Hospital Case Medical Center

ClinicalTrials.gov Identifier:

NCT01410305

First received: August 4, 2011

Last updated: June 24, 2016

Last verified: June 2016

History of Changes

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:

MedlinePlus related topics: HIV/AIDS Vitamin D Vitamin D Deficiency

Drug Information available for: Vitamin D

U.S. FDA Resources

Further study details as provided by Grace McComsey, University Hospital Case Medical Center:

Primary Outcome Measures:

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


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)

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 (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

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

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


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 ( US NIH Grant/Contract Award Number )
Study First Received:	August 4, 2011
Last Updated:	June 24, 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

ClinicalTrials.gov processed this record on May 25, 2017

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