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
|
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Condition or disease |
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Vitamin D Deficiency |
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 |

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

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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 |
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

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
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 |
Principal Investigator: | Grace McComsey, MD | University Hospitals Cleveland Medical Center | |
Principal Investigator: | Allison Ross Eckard, MD | Emory-Children's Center |
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 |