Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-02-19 @ 8:44 AM
Study NCT ID:
NCT01585051
Status:
COMPLETED
Last Update Posted:
2012-04-25
First Post:
2012-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Vitamin D Supplementation on Blood Pressure and HbA1c Levels in Patients With T2D
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': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-24', 'studyFirstSubmitDate': '2012-04-23', 'studyFirstSubmitQcDate': '2012-04-24', 'lastUpdatePostDateStruct': {'date': '2012-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HBA1-c levels', 'timeFrame': '3 and 6 months'}, {'measure': '24 hour mean blood pressure', 'timeFrame': '3 and 6 months'}], 'secondaryOutcomes': [{'measure': 'plasma glucose', 'timeFrame': '3 and 6 months'}, {'measure': 'HOMA', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vitamin D', 'blood pressure', 'typ 2 diabetes mellitus', 'blood glucose', 'HbA1c'], 'conditions': ['Diabetes Mellitus Type 2']}, 'referencesModule': {'references': [{'pmid': '24652692', 'type': 'DERIVED', 'citation': 'Jehle S, Lardi A, Felix B, Hulter HN, Stettler C, Krapf R. Effect of large doses of parenteral vitamin D on glycaemic control and calcium/phosphate metabolism in patients with stable type 2 diabetes mellitus: a randomised, placebo-controlled, prospective pilot study. Swiss Med Wkly. 2014 Mar 20;144:w13942. doi: 10.4414/smw.2014.13942.'}]}, 'descriptionModule': {'briefSummary': 'The effect of administration of vitamin D is tested on the long-term control of blood sugar (as measured by HbA1-c levels in blood) and mean blood pressure (as measured by 24 hour blood pressure profiles)in patients with stable type 2 diabetes mellitus'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Men and women, ages ≥18 years\n* Official diagnostic criteria for type 2 diabetes fulfilled in patients on any type of oral or parenteral glucose-lowering treatment\n* Independent living at home\n* On stable regimen of BP meds (if any) with BP well controlled and/or K supplement (if any) for 2 months and which is deemed unlikely to change during the study\n* Stable glucose control for 2 months by any approved method including insulin\n\nExclusion criteria\n\n* Patients with type 1 diabetes (or insulin-requiring diabetes of unclear type)\n* Patients on hemodialysis, with hyperparathyroidism or active cancer disease\n* Patients with known metabolic bone disease\n* Laboratory evidence of kidney (eGFR \\< 60 ml/min) or liver disease\n* Dietary calcium intake exceeding 1500mg/d (as estimated by dietary history)\n* 25(OH) vitamin D levels at baseline \\> 70 nmol/L\n* Calciuria (\\> 8 mmol/24 hours as measured by 24 hour urine collections)\n* Hypo- and hypercalcemias and hypo- and hyperphosphatemias of any cause\n* Medications that affect vitamin D metabolism (e.g. antiepileptic drugs, calcimimetics, 1-34 PTH (Forsteo) vitamin D therapy over and above 400U daily 6 months prior to enrollment and during the study)\n* Foreseeable need for adaptation of either glucose- or blood pressure lowering during the next 6 months as decided by the family physician or the treating diabetologist - see above\n* History of binge eating or wt gain or loss exceeding 6 kg in past 18 months\n* Patients on any type of inhibitors of plasma coagulation (i.e. coumarine, heparins)'}, 'identificationModule': {'nctId': 'NCT01585051', 'briefTitle': 'Effect of Vitamin D Supplementation on Blood Pressure and HbA1c Levels in Patients With T2D', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Baselland Bruderholz'}, 'officialTitle': 'Effect of Administration of 25(OH) Vitamin on Mean 24 Hour Blood Pressure and HBA1c Levels in Patients With Stable Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'x335/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'vitamin D', 'description': 'Intervention: Intramuscular injection of 300 000 U of 25(OH)vitamin D', 'interventionNames': ['Drug: 25(OH) vitamin D']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'administration of 0.9 % NaCl as a placebo', 'interventionNames': ['Drug: 0.9 % NaCl']}], 'interventions': [{'name': '25(OH) vitamin D', 'type': 'DRUG', 'description': '300 000 U intramuscularly, one dosage, in subjects with 25 (OH) vit D levels below 80 nmol/L, another dosage of 150 000 U after 3 months if 25(OH)vit D levels continue to be below 80 nmol/L.', 'armGroupLabels': ['vitamin D']}, {'name': '0.9 % NaCl', 'type': 'DRUG', 'description': '1 ml of 0.9 % of NaCl at the beginning and 0.5 ml of 0.9 % NaCl after three months', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-4101', 'city': 'Bruderholz/Basel', 'state': 'Basel-Landschaft', 'country': 'Switzerland', 'facility': 'Department of medicine, Kantonsspital Bruderholz'}], 'overallOfficials': [{'name': 'Reto Krapf, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine, Kantonsspital Bruderholz, University of Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Baselland Bruderholz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Reto Krapf', 'investigatorAffiliation': 'Kantonsspital Baselland Bruderholz'}}}}