Vit D and HIV-Cardiovascular Disease in Children and Young Adults Vitamin D and HIV-CVD in Children and Young Adults
This study is ongoing, but not recruiting participants.
Sponsor:
University Hospital Case Medical Center
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: December 18, 2014
Last verified: December 2014
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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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01410305
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 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 Hospital Case Medical Center |
| ClinicalTrials.gov Identifier: | NCT01410305 History of Changes |
| Other Study ID Numbers: | 1Ro1HD070490-01 |
| Study First Received: | August 4, 2011 |
| Last Updated: | December 18, 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:
|
Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders |
ClinicalTrials.gov processed this record on February 27, 2015