Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-01-02 @ 5:24 AM
Study NCT ID:
NCT00960635
Status:
COMPLETED
Last Update Posted:
2009-08-18
First Post:
2009-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunointervention With Calcitriol in New-Onset Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002117', 'term': 'Calcitriol'}], 'ancestors': [{'id': 'D004100', 'term': 'Dihydroxycholecalciferols'}, {'id': 'D006887', 'term': 'Hydroxycholecalciferols'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'PREVENTION'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-17', 'studyFirstSubmitDate': '2009-08-17', 'studyFirstSubmitQcDate': '2009-08-17', 'lastUpdatePostDateStruct': {'date': '2009-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['new-onset'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '20357369', 'type': 'DERIVED', 'citation': 'Walter M, Kaupper T, Adler K, Foersch J, Bonifacio E, Ziegler AG. No effect of the 1alpha,25-dihydroxyvitamin D3 on beta-cell residual function and insulin requirement in adults with new-onset type 1 diabetes. Diabetes Care. 2010 Jul;33(7):1443-8. doi: 10.2337/dc09-2297. Epub 2010 Mar 31.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, two-arm, placebo-controlled phase-2 trial to determine whether the daily intake of 1,25-dihydroxy-vitamin D3 \\[1,25(OH)2D3\\], improves beta cell function in patients with recently diagnosed type 1 diabetes. The treatment consists of the daily oral administration of 0.25 µg 1,25(OH)2D3 or placebo for 9 months and an equal follow-up time without supplementation. Fasting, peak and AUC C-peptide concentrations during a 2-hour mixed meal tolerance test are measured at the beginning of the study, as well as at the end of the treatment and the follow-up period in month 9 and 18. The null hypothesis is that there is no difference between 1,25(OH)2D3 treated subjects and the placebo group in the AUC C-peptide at month 18.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New onset Typ 1 diabetes (\\< 6 weeks insulin therapy)\n* Age 18-39 years\n* GADA and/or IA-2A positive\n\nExclusion Criteria:\n\n* Kidney disease\n* Pregnancy\n* Lactating'}, 'identificationModule': {'nctId': 'NCT00960635', 'briefTitle': 'Immunointervention With Calcitriol in New-Onset Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Institut fur Diabetesforschung, Munich, Germany'}, 'officialTitle': 'Immunointervention With 1,25-dihydroxy-vitamin D3 in New-onset Type 1 Diabetes', 'orgStudyIdInfo': {'id': '336/00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'calcitriol', 'interventionNames': ['Drug: 1,25-dihydroxy-vitamin D3 (calcitriol)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'pill without agent', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': '1,25-dihydroxy-vitamin D3 (calcitriol)', 'type': 'DRUG', 'armGroupLabels': ['calcitriol']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'pill without agent', 'armGroupLabels': ['pill without agent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80804', 'city': 'Munich', 'country': 'Germany', 'facility': 'Institut fuer Diabetesforschung', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Anette G Ziegler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut fuer Diabetesforschung'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut fur Diabetesforschung, Munich, Germany', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Anette Ziegler, MD', 'oldOrganization': 'Institut fuer Diabetesforschung'}}}}