Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT00850694
Status:
COMPLETED
Last Update Posted:
2017-04-10
First Post:
2009-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D Deficiency in Obese Adolescent Girls and Influence of Vitamin D on Insulin Secretion and Sensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-07', 'studyFirstSubmitDate': '2009-02-23', 'studyFirstSubmitQcDate': '2009-02-24', 'lastUpdatePostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the prevalence of subclinical vitamin D deficiency in obese female adolescents.', 'timeFrame': 'At study entry'}], 'secondaryOutcomes': [{'measure': 'To assess the relationship of serum 25 (OH) D statuses to insulin and glucose concentrations during an OGTT and to serum transaminases and CRP.', 'timeFrame': 'At study entry'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vitamin D deficiency', 'Obesity', 'Insulin resistance', 'Glucose tolerance'], 'conditions': ['Vitamin D Deficiency', 'Obesity', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'Sub-clinical vitamin D deficiency is a commonly unrecognized disorder in obese adolescents. The investigators hypothesize vitamin D deficiency will be highly prevalent in obese adolescents and those who are vitamin D deficient will be more insulin resistant.', 'detailedDescription': 'This is a cross-sectional study of obese female adolescents matched for age, sex and pubertal staging. Serum 25-OH vitamin D, intact PTH , lipid profile, serum CRP measurements and oral glucose tolerance tests (with glucose and insulin level measurements) will be done to assess the prevalence of vitamin D deficiency and to assess the insulin sensitivity- resistance indices.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Obese female adolescents', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female adolescents\n* Obese: BMI \\> 95th percentile\n* Menarchal\n* Tanner stage ≥ 4\n\nExclusion Criteria:\n\n* Children with diabetes, other endocrine or acute or chronic medical illnesses, children on oral contraceptive pills, diuretics and anticonvulsant medications'}, 'identificationModule': {'nctId': 'NCT00850694', 'briefTitle': 'Vitamin D Deficiency in Obese Adolescent Girls and Influence of Vitamin D on Insulin Secretion and Sensitivity', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Assessment of Prevalence of Vitamin D Deficiency in Obese Adolescent Girls and Influence of Vitamin D on Insulin Secretion and Sensitivity', 'orgStudyIdInfo': {'id': 'F061228001'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Obese female adolescents'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Children's Hospital, Universiy of Alabama at Birmingham", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Ambika Ashraf', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Pediatrics', 'investigatorFullName': 'Ambika Ashraf, M.D.', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}