Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-01 @ 5:52 PM
Study NCT ID:
NCT01662193
Status:
UNKNOWN
Last Update Posted:
2012-08-13
First Post:
2012-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Vitamin D and Calcium Supplementation on Inflammatory Biomarkers and Adypocytokines in Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D002119', 'term': 'Calcium Carbonate'}], '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'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'lastUpdateSubmitDate': '2012-08-10', 'studyFirstSubmitDate': '2012-07-29', 'studyFirstSubmitQcDate': '2012-08-07', 'lastUpdatePostDateStruct': {'date': '2012-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in inflammatory biomarkers from baseline at 8 weeks', 'timeFrame': '8 weeks', 'description': 'including:IL-6, TNF-alpha, hs-CRP'}, {'measure': 'change in adipocytokines from baseline at 8 weeks', 'timeFrame': '8 weeks', 'description': 'including: adiponectin and leptin'}], 'secondaryOutcomes': [{'measure': 'change in weight (Kg) from baseline at 8 weeks', 'timeFrame': '8 weeks'}, {'measure': 'change in lipid profile from baseline at 8 weeks', 'timeFrame': '8 weeks', 'description': 'including: LDL, HDL, total cholesterol, TG'}, {'measure': 'change in serum Glucose from baseline at 8 weeks', 'timeFrame': '8 weeks'}, {'measure': 'change in height (Cms) from baseline at 8 weeks', 'timeFrame': '8 weeks'}, {'measure': 'change in hip circumference (Cms) from baseline at 8 weeks', 'timeFrame': '8 weeks'}, {'measure': 'change in waist circumference (Cms) from baseline at 8 weeks', 'timeFrame': '8 weeks'}, {'measure': 'change in serum Insulin from baseline at 8 weeks', 'timeFrame': '8 weeks'}, {'measure': 'change in HbA1C from baseline at 8 weeks', 'timeFrame': '8 weeks'}, {'measure': 'change in blood pressure from baseline at 8 weeks', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cholecalciferol', 'Calciol', 'vitamin D3', 'Diabetes Mellitus', 'Diabetes Mellitus Type 2', 'glucose metabolism disorders', 'ergocalciferol', 'calcium', 'adipicytokines', 'inflammatory biomarkers'], 'conditions': ['Nutritional and Metabolic Disease']}, 'referencesModule': {'references': [{'pmid': '25738212', 'type': 'DERIVED', 'citation': 'Tabesh M, Azadbakht L, Faghihimani E, Tabesh M, Esmaillzadeh A. Effects of Calcium Plus Vitamin D Supplementation on Anthropometric Measurements and Blood Pressure in Vitamin D Insufficient People with Type 2 Diabetes: A Randomized Controlled Clinical Trial. J Am Coll Nutr. 2015;34(4):281-9. doi: 10.1080/07315724.2014.905761. Epub 2015 Mar 4.'}, {'pmid': '25215557', 'type': 'DERIVED', 'citation': 'Tabesh M, Azadbakht L, Faghihimani E, Tabesh M, Esmaillzadeh A. Calcium-vitamin D cosupplementation influences circulating inflammatory biomarkers and adipocytokines in vitamin D-insufficient diabetics: a randomized controlled clinical trial. J Clin Endocrinol Metab. 2014 Dec;99(12):E2485-93. doi: 10.1210/jc.2014-1977.'}, {'pmid': '25005333', 'type': 'DERIVED', 'citation': 'Tabesh M, Azadbakht L, Faghihimani E, Tabesh M, Esmaillzadeh A. Effects of calcium-vitamin D co-supplementation on metabolic profiles in vitamin D insufficient people with type 2 diabetes: a randomised controlled clinical trial. Diabetologia. 2014 Oct;57(10):2038-47. doi: 10.1007/s00125-014-3313-x. Epub 2014 Jul 10.'}]}, 'descriptionModule': {'briefSummary': 'The epidemic of type 2 diabetes is an enormous public health problem in all parts of the world, with 366 million cases by 2030. Chronic inflammation has been postulated to play a role in the pathogenesis of type 2 diabetes. High levels of adiponectin and inflammatory biomarkers are known as a new risk factor for diabetes. There is accumulating evidence suggesting that altered vitamin D and calcium homeostasis affect the development of type 2 diabetes, but it is still unclear whether that effects are through reducing the level of adipocytokines and inflammatory biomarkers or not. This study has been designed to evaluate the effects of vitamin D and calcium supplementations alone and in combination on inflammatory biomarkers and adypocytokines in type 2 diabetic patients.\n\nThis study is a single masked, controlled randomized trial with period of 8 weeks. 120 diabetic patients who met the inclusion criteria will enroll in this study. Subjects will randomly assign in to four groups. Randomization will be achieved by permuted blocks with stratification by age, sex, BMI, type of diabetes and dose of medication. Group1 will receive 50000 IU of vitamin D3 per week plus calcium placebo, group2 will received 1000 mg of calcium carbonate per day plus vitamin D placebo, group 3 will receive 50000 IU of vitamin D3 plus 100 of mg calcium carbonate per day and group four will receive calcium and vitamin D placebos. Total cholesterol, HDL, LDL, serum triglyceride, serum glucose, serum insulin, HbA1C, leptin, adiponectin and inflammatory biomarkers such as TNF-alpha, IL-6 and high sensitivity C reactive protein (hs-CRP) will be determine by taking blood samples at the baseline and at the end of intervention. Systolic and diastolic blood pressure and anthropometric measurements (height, weight, hip and waist circumferences) will be measured at the baseline and after 8 weeks of intervention. 3 dietary records and 3 physical activity records will be taken at 2,4 and 6 week of intervention to make sure that all subjects maintain their usual diet and physical activity during intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* more than 30 years old\n* have no history of renal failure, cancer, liver diseases, thyroid diseases or any other inflammatory diseases\n* have no allergy\n* do not use any tobacco products\n* not using corticosteroids\n* not consuming any kinds of vitamin D or calcium supplement\n* have not more than 4 kilograms weight change during last 3 months\n\nExclusion Criteria:\n\n* pregnancy\n* insulin dependent diabetes'}, 'identificationModule': {'nctId': 'NCT01662193', 'briefTitle': 'Effects of Vitamin D and Calcium Supplementation on Inflammatory Biomarkers and Adypocytokines in Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'Effects of Vitamin D and Calcium Supplementation on Inflammatory Biomarkers and Adypocytokines in Diabetic Patients', 'orgStudyIdInfo': {'id': '190136'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vitamin D3', 'description': 'vitamin D3 supplement 50000 IU vitamin D3 per week', 'interventionNames': ['Dietary Supplement: vitamin D3 supplement']}, {'type': 'EXPERIMENTAL', 'label': 'calcium supplement', 'description': 'calcium supplement 1000 mg calcium carbonate daily', 'interventionNames': ['Dietary Supplement: calcium supplement']}, {'type': 'EXPERIMENTAL', 'label': 'vitamin D and calcium supplement', 'description': 'vitamin D3 and calcium supplementation 50000 IU vitamin D3 per week and 1000 mg calcium carbonate daily', 'interventionNames': ['Dietary Supplement: vitamin D3 and calcium supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'vitamin D3 supplement', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['cholecalciferol'], 'armGroupLabels': ['vitamin D3']}, {'name': 'calcium supplement', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['calcium carbonate'], 'armGroupLabels': ['calcium supplement']}, {'name': 'vitamin D3 and calcium supplement', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['cholecalciferol and calcium carbonate'], 'armGroupLabels': ['vitamin D and calcium supplement']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Isfahan', 'state': 'Isfahan', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'esmaillzadeh, PhD', 'role': 'CONTACT', 'email': 'esmaillzadeh@hlth.mui.ac.ir'}, {'name': 'marjan tabesh, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical School of Isfahan', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}], 'centralContacts': [{'name': 'marjan tabesh, MS', 'role': 'CONTACT', 'email': 'tabesh@hlth.mui.ac.ir', 'phone': '00989131664159'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Marjan Tabesh', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}}