Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT02020694
Status:
COMPLETED
Last Update Posted:
2023-04-19
First Post:
2013-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D Supplementation for the Prevention of Cardiovascular Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-17', 'studyFirstSubmitDate': '2013-12-19', 'studyFirstSubmitQcDate': '2013-12-19', 'lastUpdatePostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in insulin sensitivity (M value)', 'timeFrame': 'Baseline, 3 months', 'description': 'Insulin sensitivity will be measured with the hyperinsulinemic euglycemic clamp technique and expressed as M value, calculated from the glucose infusion rate during the last 30 min of the clamp.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in oral glucose tolerance', 'timeFrame': 'Baseline, 3 months', 'description': 'Oral glucose tolerance will be assessed with a standard 2-hour oral glucose tolerance test (OGTT).'}, {'measure': 'Change from baseline in body composition', 'timeFrame': 'Baseline, 3 months', 'description': 'Body composition will be determined by using dual energy X-ray absorptiometry (DXA).'}, {'measure': 'Change from baseline in anthropometric parameters', 'timeFrame': 'Baseline, 3 months', 'description': 'Weight, BMI, waist and hip circumference, waist/hip ratio.'}, {'measure': 'Change form baseline in systolic and diastolic blood pressure', 'timeFrame': 'Baseline, 3 months'}, {'measure': 'Change from baseline in phosphocalcic metabolism', 'timeFrame': 'Baseline, 3 months', 'description': 'Serum vitamin D, PTH and calcium'}, {'measure': 'Change from baseline in inflammatory markers', 'timeFrame': 'Baseline, 3 months', 'description': 'Interleukin-6 (IL-6), IL-10, adiponectin, TNF-α, C-reactive protein (CRP) and fibrinogen'}]}, 'conditionsModule': {'keywords': ['Obesity', 'Insulin resistance', 'Vitamin D', 'Cardiovascular risk factors'], 'conditions': ['Obesity', 'Overweight', 'Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '22260937', 'type': 'BACKGROUND', 'citation': 'Muscogiuri G, Policola C, Prioletta A, Sorice G, Mezza T, Lassandro A, Della Casa S, Pontecorvi A, Giaccari A. Low levels of 25(OH)D and insulin-resistance: 2 unrelated features or a cause-effect in PCOS? Clin Nutr. 2012 Aug;31(4):476-80. doi: 10.1016/j.clnu.2011.12.010. Epub 2012 Jan 20.'}, {'pmid': '21209228', 'type': 'BACKGROUND', 'citation': 'Muscogiuri G, Sorice GP, Prioletta A, Policola C, Della Casa S, Pontecorvi A, Giaccari A. Will vitamin D reduce insulin resistance? Still a long way to go. Am J Clin Nutr. 2011 Mar;93(3):672-3; author reply 673-4. doi: 10.3945/ajcn.110.009068. Epub 2011 Jan 5. No abstract available.'}, {'pmid': '20587719', 'type': 'BACKGROUND', 'citation': 'Muscogiuri G, Sorice GP, Prioletta A, Policola C, Della Casa S, Pontecorvi A, Giaccari A. Association of vitamin D with insulin resistance and beta-cell dysfunction in subjects at risk for type 2 diabetes: comment to Kayaniyil et al. Diabetes Care. 2010 Jul;33(7):e99; author reply e100. doi: 10.2337/dc10-0587. No abstract available.'}, {'pmid': '20150902', 'type': 'BACKGROUND', 'citation': 'Muscogiuri G, Sorice GP, Prioletta A, Policola C, Della Casa S, Pontecorvi A, Giaccari A. 25-Hydroxyvitamin D concentration correlates with insulin-sensitivity and BMI in obesity. Obesity (Silver Spring). 2010 Oct;18(10):1906-10. doi: 10.1038/oby.2010.11. Epub 2010 Feb 11.'}, {'pmid': '29504254', 'type': 'DERIVED', 'citation': 'Cefalo CMA, Conte C, Sorice GP, Moffa S, Sun VA, Cinti F, Salomone E, Muscogiuri G, Brocchi AAG, Pontecorvi A, Mezza T, Giaccari A. Effect of Vitamin D Supplementation on Obesity-Induced Insulin Resistance: A Double-Blind, Randomized, Placebo-Controlled Trial. Obesity (Silver Spring). 2018 Apr;26(4):651-657. doi: 10.1002/oby.22132. Epub 2018 Mar 4.'}]}, 'descriptionModule': {'briefSummary': 'Hypovitaminosis D is highly prevalent in the general population, particularly in obese individuals. Besides being associated with obesity, vitamin D deficiency seems to be involved in the pathogenesis of insulin resistance and low-grade chronic inflammation. In addition, it has been reported that individuals with low vitamin D levels are at increased risk for cardiovascular diseases. A healthy diet and weight loss are cornerstones in the prevention of cardiovascular diseases. Vitamin D supplementation could increase the beneficial effects of these lifestyle interventions. The purpose of this study is to assess whether vitamin D supplementation in conjunction with a hypocaloric diet improves the cardiometabolic profile of overweight/obese subjects to a greater extent than diet alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI≥25 kg/m2\n\nExclusion Criteria:\n\n* Diabetes mellitus\n* Chronic kidney disease\n* Liver disease\n* Cholestasis\n* Cancer\n* Chronic bowel disease\n* Primary or secondary hyperparathyroidism\n* Treatment with drugs that may affect insulin sensitivity, weight or calcium/vitamin D metabolism\n* Laxative abuse\n* Changes \\>10% of usual body weight in the previous 6 months\n* Alcohol or illicit drug abuse\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02020694', 'briefTitle': 'Vitamin D Supplementation for the Prevention of Cardiovascular Risk', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'The Role of Vitamin D Supplementation in the Prevention of Cardiovascular Risk Factors', 'orgStudyIdInfo': {'id': '752/11'}, 'secondaryIdInfos': [{'id': '2011-003183-75', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D and Diet', 'description': 'Cholecalciferol (vitamin D3) 25,000 I.U./2.5 mL oral solution. 25,000 I.U. (one bottle) per week.\n\nHypocaloric diet', 'interventionNames': ['Drug: Vitamin D']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo & Diet', 'description': 'Oral solution mimicking cholecalciferol (vitamin D3) 25,000 I.U./2.5 mL. One bottle per week.\n\nHypocaloric diet', 'interventionNames': ['Drug: Placebo (for vitamin D)']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DRUG', 'armGroupLabels': ['Vitamin D and Diet']}, {'name': 'Placebo (for vitamin D)', 'type': 'DRUG', 'armGroupLabels': ['Placebo & Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'Catholic University of Sacred Heart', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Andrea Giaccari, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catholic University of the Sacred Heart'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Giaccari Andrea', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}