Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-04-04 @ 2:48 PM
Study NCT ID:
NCT01781169
Status:
COMPLETED
Last Update Posted:
2013-10-30
First Post:
2013-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vitamin D Supplementation to Obese Chinese Males
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jichangzhou@gmail.com', 'phone': '86-755-25503842', 'title': 'Dr. Ji-Chang Zhou', 'organization': 'Shenzhen Center for Chronic Disease Control'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The numbers of participants in both the obese group and normal-weight group were small.'}}, 'adverseEventsModule': {'timeFrame': 'Eight weeks of the trial for all the participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Normal-weight Group', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Obese Group', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Group', 'description': 'Oral supplementation of vitamin D.'}, {'id': 'OG001', 'title': 'Normal-weight Group', 'description': 'Oral supplementation of vitamin D.'}], 'classes': [{'title': 'Endpoint plasma 25(OH)D level', 'categories': [{'measurements': [{'value': '116.7', 'spread': '20.3', 'groupId': 'OG000'}, {'value': '181.3', 'spread': '30.2', 'groupId': 'OG001'}]}]}, {'title': 'Baseline plasma 25(OH)D level', 'categories': [{'measurements': [{'value': '46.1', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '52.8', 'spread': '17.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Endpoint and baseline of the 8 weeks' trial", 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Obese Group', 'description': 'Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.'}, {'id': 'FG001', 'title': 'Normal-weight Group', 'description': 'Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited at a medical clinic (Health Service Center of Shuiku Community, Shenzhen, China) in May, 2011.', 'preAssignmentDetails': 'After enrollment, baseline information of the volunteers including vitamin D nutritional status, health records, etc. were evaluated. Including and excluding criteria were used to select the subjects who were suitable for the intervention trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Normal-weight Group'}, {'id': 'BG001', 'title': 'Obese Group'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.4', 'spread': '8', 'groupId': 'BG000'}, {'value': '44.7', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '39.5', 'spread': '9.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-27', 'studyFirstSubmitDate': '2013-01-25', 'resultsFirstSubmitDate': '2013-05-29', 'studyFirstSubmitQcDate': '2013-01-29', 'lastUpdatePostDateStruct': {'date': '2013-10-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-26', 'studyFirstPostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L)', 'timeFrame': "Endpoint and baseline of the 8 weeks' trial"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vitamin D,', 'Oral supplementation,', 'Obese males'], 'conditions': ['Obesity', 'Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '21177785', 'type': 'BACKGROUND', 'citation': 'Heaney RP, Recker RR, Grote J, Horst RL, Armas LA. Vitamin D(3) is more potent than vitamin D(2) in humans. J Clin Endocrinol Metab. 2011 Mar;96(3):E447-52. doi: 10.1210/jc.2010-2230. Epub 2010 Dec 22.'}, {'pmid': '9519960', 'type': 'RESULT', 'citation': 'Malabanan A, Veronikis IE, Holick MF. Redefining vitamin D insufficiency. Lancet. 1998 Mar 14;351(9105):805-6. doi: 10.1016/s0140-6736(05)78933-9. No abstract available.'}, {'pmid': '17634462', 'type': 'RESULT', 'citation': 'Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis: Oral Supplementation of Vitamin D can Reduce Hypersecretion of Parathyroid Hormone and Insulin Resistance in Obese Chinese Males.\n\nProtocol: Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) or eight weeks to the obese males compared with the normal-weight males. Index measures were conducted at baseline and endpoint.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '66 Years', 'minimumAge': '23 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* body mass index (BMI) ≥ 28kg/m2 or 18.5 ≤ BMI \\< 24 (kg/m2)\n* non vegetarian Han Chinese and did not smoke, drink, nor take vitamin D supplements for \\> 2 y\n* fasting serum glucose \\< 7.0 mmol/L\n* serum glucose of 2 hr after 75 g oral glucose loading \\< 11.1 mmol/L\n* normal functioning of liver and kidney evaluated by alkaline phosphatase, aspartate aminotransferase, creatinine, and uric acid\n\nExclusion Criteria:\n\n* not match the above inclusion criteria\n* diagnosed as having any organic diseases were excluded'}, 'identificationModule': {'nctId': 'NCT01781169', 'briefTitle': 'Vitamin D Supplementation to Obese Chinese Males', 'organization': {'class': 'OTHER', 'fullName': 'Shenzhen Center for Chronic Disease Control'}, 'officialTitle': 'Health Effect of Oral Vitamin D Supplementation on Obese Chinese Males', 'orgStudyIdInfo': {'id': 'VD50kIU2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Obese group', 'description': 'Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.', 'interventionNames': ['Dietary Supplement: Oral supplementation of vitamin D']}, {'type': 'EXPERIMENTAL', 'label': 'Normal-weight group', 'description': 'Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.', 'interventionNames': ['Dietary Supplement: Oral supplementation of vitamin D']}], 'interventions': [{'name': 'Oral supplementation of vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) for eight weeks to the obese males compared with the normal-weight males. The chemical form of vitamin D is cholecalciferol capsuled as fine powder.', 'armGroupLabels': ['Normal-weight group', 'Obese group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '518020', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': 'Shenzhen Center for Chronic Disease Control', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'overallOfficials': [{'name': 'Ji-Chang Zhou, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shenzhen Center for Chronic Disease Control'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen Center for Chronic Disease Control', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danone Institute China Diet Nutrition Research and Communication', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Dean of Molecular Biology Lab', 'investigatorFullName': 'Zhou Ji-Chang', 'investigatorAffiliation': 'Shenzhen Center for Chronic Disease Control'}}}}