Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-03-15 @ 4:30 AM
Study NCT ID:
NCT01410305
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
2011-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D and HIV-Cardiovascular Disease in Children and Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'plasma, serum, PBMCs, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-24', 'studyFirstSubmitDate': '2011-08-04', 'studyFirstSubmitQcDate': '2011-08-04', 'lastUpdatePostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vitamin D levels', 'timeFrame': 'One time point at entry', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vitamin D Deficiency', 'HIV+ Children', 'HIV+ Young Adults'], 'conditions': ['Vitamin D Deficiency']}, 'descriptionModule': {'briefSummary': 'The relationship of Vitamin D levels in children and young adults to atherosclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any HIV+ patient between the ages of 8 and 25 and matched HIV- controls matched by age and race.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria - Documentation of HIV Infection Between ages of 8 and 25\n\n* On stable ART for at least 12 weeks for the HIV+ patients\n* Cumulative duration of ART for at least 48 weeks for HIV + patients\n* Healthy child/young adult with age and race matched to HIV+ patient for the HIV- controls\n* Absence of HIV based on medical and medication history\n\nExclusion Criteria:\n\n* Taking \\> 800 IU of Vitamin D per day\n* Parathyroid or Calcium disorders\n* Acute illness and active inflammatory condition\n* Chronic illnesses that include malignancy, diabetes, CAD\n* Pregnancy and lactation\n* Creatinine Clearance \\<50 ml/min\n* Hgb \\< 9.0 g/dL\n* AST and ALT \\> 2.5 upper limits of normal'}, 'identificationModule': {'nctId': 'NCT01410305', 'briefTitle': 'Vitamin D and HIV-Cardiovascular Disease in Children and Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Vitamin D Metabolism Inflammation, and Cardiovascular Risk in HIV-infected Children and Young Adults', 'orgStudyIdInfo': {'id': '1R01HD070490-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01HD070490-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV+', 'description': 'HIV Positive children or young people between the ages of 8 and 25'}, {'label': 'HIV Negative', 'description': 'HIV Negative matched controls by age and race'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Emory Chldren's Center", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Case Medical Center, Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Grace McComsey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}, {'name': 'Allison Ross Eckard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Emory-Children's Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': "Emory-Children's Center", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics and Medicine', 'investigatorFullName': 'Grace McComsey', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}