Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT02101151
Status:
COMPLETED
Last Update Posted:
2014-04-02
First Post:
2014-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Vitamin D Supplementation on the Metabolic Control and Body Composition of Type 2 Diabetes Subjects in Ajman (UAE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}, {'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': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-29', 'studyFirstSubmitDate': '2014-03-26', 'studyFirstSubmitQcDate': '2014-03-29', 'lastUpdatePostDateStruct': {'date': '2014-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'glycemic control', 'timeFrame': '6 months', 'description': 'HbA1c, Fasting Blood glucose, C-peptide'}], 'secondaryOutcomes': [{'measure': 'Lipid Profile', 'timeFrame': '6 months', 'description': 'Serum Total cholesterol, LDL-C, HDL-C, Triglyceride, Apolipoprotein A and B'}, {'measure': 'Vitamin D', 'timeFrame': '6 months', 'description': 'Serum 25-hydroxyvitamin D, Parathyroid hormone, Calcium, Phosphate, Alkaline phosphatase'}, {'measure': 'Other metabolic markers', 'timeFrame': '6 months', 'description': 'High sensitive C-Reactive Protein, Creatinine, Thyroid stimulating hormone, Systolic Blood pressure, Diastolic Blood pressure'}, {'measure': 'Obesity Parameter', 'timeFrame': '6 monhts', 'description': 'Weight, BMI, waist circumference, Fat mass, Muscle mass, water mass'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Type 2 diabetes mellitus', 'vitamin D', 'cholecalciferol', 'obesity'], 'conditions': ['Type 2 Diabetes Mellitus', 'Obesity', 'Hypovitaminosis D']}, 'referencesModule': {'references': [{'pmid': '25892603', 'type': 'DERIVED', 'citation': 'Sadiya A, Ahmed SM, Carlsson M, Tesfa Y, George M, Ali SH, Siddieg HH, Abusnana S. Vitamin D3 supplementation and body composition in persons with obesity and type 2 diabetes in the UAE: A randomized controlled double-blinded clinical trial. Clin Nutr. 2016 Feb;35(1):77-82. doi: 10.1016/j.clnu.2015.02.017. Epub 2015 Mar 24.'}, {'pmid': '25406966', 'type': 'DERIVED', 'citation': 'Sadiya A, Ahmed SM, Carlsson M, Tesfa Y, George M, Ali SH, Siddieg HH, Abusnana S. Vitamin D supplementation in obese type 2 diabetes subjects in Ajman, UAE: a randomized controlled double-blinded clinical trial. Eur J Clin Nutr. 2015 Jun;69(6):707-11. doi: 10.1038/ejcn.2014.251. Epub 2014 Nov 19.'}]}, 'descriptionModule': {'briefSummary': 'The incidence of type 2 diabetes mellitus and obesity is increasing at an alarming rate both nationally and worldwide. Accumulating evidence suggests that serum cholecalciferol levels may be inversely related to the prevalence of diabetes, insulin resistance and metabolic syndrome. However, to demonstrate a causal relation between vitamin D and glucose metabolism, evidence from randomized and adequately powered placebo-controlled intervention trials is needed.The trials available on the effect of Vitamin D supplementation are not conclusive. Hence, the purpose of this study was to conduct a double-blind randomized trial in Vitamin D deficient obese type 2 diabetic Emirati population to clarify the effect of vitamin D supplementation on glycemic control and obesity parameters.', 'detailedDescription': 'Vitamin D insufficiency has been reported as a risk factor for the development of type 1 and type 2 diabetes mellitus. In contrast to the findings of the observational studies, the supplementation trials in type 2 diabetes mellitus (T2DM) do not report any definitive conclusions, but it does suggest that supplementation at an early stage in the development of diabetes may be of benefit in delaying progression to clinical T2DM by increasing the pancreatic insulin release and improved insulin resistance plus impaired glucose tolerance.There is also speculation on role of vitamin D in physiology of weight loss and body composition.However, there have been multiple inconsistencies within the reported trial i.e. sample size, dose of vitamin D, frequency of supplementation, and population studied.\n\nHence the randomised clinical trial was undertaken to study the effect of vitamin D (Cholecalciferol) supplementation on metabolic markers and obesity parameters in the vitamin D deficient obese type 2 diabetic subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* United Arab Emirates national\n* Male or Female\n* Age 30-65 years\n* Diagnosed as type 2 diabetes\n* Body Mass Index ≥30 kg/m2\n* Serum 25 hydroxy Vitamin D ≤ 50nmol/L\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* History or evidence of liver failure (elevated liver function tests) or renal failure ( elevated creatinine)\n* History of malabsorption syndrome.\n* On vitamin D Supplementation\n* On hormone replacement therapy\n* On corticosteroids, anticonvulsants, AIDS medication'}, 'identificationModule': {'nctId': 'NCT02101151', 'acronym': 'VDIS', 'briefTitle': 'Effect of Vitamin D Supplementation on the Metabolic Control and Body Composition of Type 2 Diabetes Subjects in Ajman (UAE)', 'organization': {'class': 'OTHER', 'fullName': 'Rashid Centre for Diabetes and Research'}, 'officialTitle': 'Effect of Vitamin D Supplementation on the Metabolic Control and Body Composition of Type 2 Diabetes Subjects in Ajman (UAE)', 'orgStudyIdInfo': {'id': 'VDIS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D3 group', 'description': 'supplemented with 6000IU cholecalciferol/day for 3 months, followed by 3000 IU cholecalciferol/day for next 3 months', 'interventionNames': ['Dietary Supplement: Vitamin D3(cholecalciferol)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo (starch) capsules identical to vitamin D capsules in appearance', 'interventionNames': ['Dietary Supplement: Vitamin D3(cholecalciferol)']}], 'interventions': [{'name': 'Vitamin D3(cholecalciferol)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['cholecalciferol'], 'armGroupLabels': ['Placebo group', 'Vitamin D3 group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ajman', 'country': 'United Arab Emirates', 'facility': 'Rashid Centre for Diabetes and Research', 'geoPoint': {'lat': 25.40177, 'lon': 55.47878}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rashid Centre for Diabetes and Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Nutritionist', 'investigatorFullName': 'Dr.Amena Sadiya', 'investigatorAffiliation': 'Rashid Centre for Diabetes and Research'}}}}