Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT01497132
Status:
COMPLETED
Last Update Posted:
2014-09-10
First Post:
2011-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}], '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'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-09', 'studyFirstSubmitDate': '2011-12-20', 'studyFirstSubmitQcDate': '2011-12-21', 'lastUpdatePostDateStruct': {'date': '2014-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beta cell function', 'timeFrame': '8 weeks', 'description': 'Assessed by hyperglycemic clamp investigation'}], 'secondaryOutcomes': [{'measure': 'Insulin sensitivity', 'timeFrame': '8 weeks', 'description': 'Assessed by hyperglycemic clamp investigation'}, {'measure': 'Glucose tolerance', 'timeFrame': '8 weeks', 'description': 'Assessed by OGTT'}, {'measure': 'Hypercalcemia', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Glucose Intolerance', 'Vitamin D Deficiency']}, 'referencesModule': {'references': [{'pmid': '26786573', 'type': 'DERIVED', 'citation': 'Wagner H, Alvarsson M, Mannheimer B, Degerblad M, Ostenson CG. No Effect of High-Dose Vitamin D Treatment on beta-Cell Function, Insulin Sensitivity, or Glucose Homeostasis in Subjects With Abnormal Glucose Tolerance: A Randomized Clinical Trial. Diabetes Care. 2016 Mar;39(3):345-52. doi: 10.2337/dc15-1057. Epub 2016 Jan 19.'}, {'pmid': '25835492', 'type': 'DERIVED', 'citation': 'Mannheimer B, Wagner H, Ostenson CG, Diczfalusy U. No impact of vitamin D on the CYP3A biomarker 4beta-hydroxycholesterol in patients with abnormal glucose regulation. PLoS One. 2015 Apr 2;10(4):e0121984. doi: 10.1371/journal.pone.0121984. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if treatment with vitamin D increase beta cell function and insulin sensitivity in subjects with pre-diabetes or newly diagnosed diabetes mellitus type 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meeting criteria for IFG, IGT, IFG+IGT or diabetes mellitus at OGTT.\n* BMI ≤ 32 kg/m2.\n* HbA1c ≤ 7.0 % (MonoS) or ≤ 63 mmol/mol (IFCC).\n* Fasting plasma glucose \\< 9 mmol/l\n* S-25-OH-vitamin D3 \\< 75 nmol/l.\n\nExclusion Criteria:\n\n* Treatment with any vitamin D preparation.\n* Regular sun-bathing in solarium.\n* Hypercalcemia at screening, defined as free s-calcium \\> 1.35 mmol/l.\n* Hyperphosphatemia at screening, defined as s-phosphate \\> 1.5 mmol/l.\n* Sarcoidosis or other granulomatous disease.\n* Treatment with phenytoin, barbiturates, rifampicin, isoniazid, cardiac glycosides, orlistat or colestyramin.\n* Impaired hepatic function.\n* Impaired renal function\n* Cardiac disease defined as:\n\n * Unstable angina pectoris\n * Myocardial infarction within the last 6 months\n * Congestive heart failure NYHA class III and IV\n* Cerebral stroke within the last 6 months.\n* Anti-diabetic medication of any kind.\n* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.'}, 'identificationModule': {'nctId': 'NCT01497132', 'acronym': 'EVIDENS', 'briefTitle': 'Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2 - EVIDENS', 'orgStudyIdInfo': {'id': 'DvitamininDM2_v1_110815'}, 'secondaryIdInfos': [{'id': '2010-024487-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D3', 'interventionNames': ['Drug: Vitamin D3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vitamin D3', 'type': 'DRUG', 'otherNames': ['Vigantol oil'], 'description': 'Oral drops 30000 IU weekly', 'armGroupLabels': ['Vitamin D3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17176', 'city': 'Stockholm', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'Dpt of Endocrinology, Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Henrik Wagner, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Henrik Wagner', 'investigatorAffiliation': 'Karolinska Institutet'}}}}