Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-28 @ 2:27 PM
Study NCT ID:
NCT01170468
Status:
TERMINATED
Last Update Posted:
2018-03-07
First Post:
2010-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Vitamin D Reduce Risk of Developing Type II DM in High Risk Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'whyStopped': 'inadequate enrollement', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2014-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-06', 'studyFirstSubmitDate': '2010-07-25', 'studyFirstSubmitQcDate': '2010-07-26', 'lastUpdatePostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of DM', 'timeFrame': '2 years', 'description': 'Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge.'}], 'secondaryOutcomes': [{'measure': 'slope of fasting glucose level', 'timeFrame': '2 years'}, {'measure': 'slope of 2-hour post challenge glucose level', 'timeFrame': '2 years'}, {'measure': 'area under the curve of BP', 'timeFrame': '2 years'}, {'measure': 'area under the curve of weight', 'timeFrame': '2 years'}, {'measure': 'area under the curve of 25 OH vitamin D level', 'timeFrame': '2 years'}, {'measure': 'fasting insulin to glucose ratio', 'timeFrame': '2 years'}, {'measure': 'incidence of hypercalcemia', 'timeFrame': '2 years'}, {'measure': 'incidence of hypercalciuria', 'timeFrame': '2 years'}, {'measure': 'time to develop DM', 'timeFrame': '2 years', 'description': 'Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prediabetics', 'DM', 'vitamin D'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Both vitamin D deficiency and type II DM/prediabetes are highly prevalent. Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. A cause-effect relationship between vitamin D deficiency and the development of type II DM has not been established.\n\nThe investigators plan to conduct a 2 year, double blind, randomized, placebo controlled trial on the effect of vitamin D3 supplement on the incidence of type II DM in high risk individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults living in Riyadh area with impaired fasting glucose or/and impaired glucose tolerance (prediabetics) and total 25 OH vitamin D level between 10-30 nmol/l\n* Who consume no more than one serving of milk/day\n* Do not take vitamin supplement\n* Habitually have less than 10 hour of sun exposure per week\n* Don't suffer from granulomatus conditions, liver disease, kidney disease, or diabetes\n* Don't take anticonvulsants, barbiturates, steroids, or antidiabetic medications."}, 'identificationModule': {'nctId': 'NCT01170468', 'briefTitle': 'Does Vitamin D Reduce Risk of Developing Type II DM in High Risk Individuals', 'organization': {'class': 'OTHER', 'fullName': 'King Faisal Specialist Hospital & Research Center'}, 'officialTitle': 'Does Vitamin D Reduce Risk of Developing Type II DM in Prediabetics? A Double Blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RAC 2101040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D3', 'description': 'Vitamin D3 5000 IU daily', 'interventionNames': ['Drug: Vitamin D3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vitamin D3', 'type': 'DRUG', 'otherNames': ['cholecalciferol'], 'description': 'Vitamin D3 5000 IU orally, daily for 2 years', 'armGroupLabels': ['Vitamin D3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo orally, daily for 2 years', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11211', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Faisal Specialist Hospital & Research Center', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Muhammad M Hammami, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Faisal Specialist Hospital & Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Faisal Specialist Hospital & Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman, Department of Clinical Studies & Empirical Ethics', 'investigatorFullName': 'Muhammad Maher Hammami', 'investigatorAffiliation': 'King Faisal Specialist Hospital & Research Center'}}}}