Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-03 @ 6:28 AM
Study NCT ID:
NCT01761669
Status:
COMPLETED
Last Update Posted:
2016-11-03
First Post:
2012-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Deficiency in Vitamin D Induced Hypercoagulation or Thrombin Generation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-02', 'studyFirstSubmitDate': '2012-12-04', 'studyFirstSubmitQcDate': '2013-01-02', 'lastUpdatePostDateStruct': {'date': '2016-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the correlation between vitamin D levels and endogenous thrombin potential', 'timeFrame': '3 month', 'description': 'one blood test'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'Working hypothesis and aims: The aim of our study is to investigate whether vitamin D deficiency could cause increased thrombin generation and a hypercoagulable state healthy volunteers.\n\nMethods:\n\nIn total 400 healthy volunteers are planned for inclusion in this trial. After signing an informed consent two blood samples will be obtained from each participant.\n\nExpected results: invastigator expect to find that volunteers with vitamin D deficiency will have thrombin generation curve compatible with hypercoagulable state and returning to normal after treatment with vitamin D'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '400 healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: age \\>18 healthy naive to drug treatment -\n\nExclusion Criteria:\n\nno exc criteria\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01761669', 'briefTitle': 'Does Deficiency in Vitamin D Induced Hypercoagulation or Thrombin Generation', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'orgStudyIdInfo': {'id': 'vitamin D'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthy voulnters', 'interventionNames': ['Drug: Vitamin D']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DRUG', 'armGroupLabels': ['healthy voulnters']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19101', 'city': 'Afula', 'country': 'Israel', 'facility': 'HaEmekMC', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}], 'overallOfficials': [{'name': 'mazen elias, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emek Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Internal Medicine C', 'investigatorFullName': 'Elias mazen', 'investigatorAffiliation': 'HaEmek Medical Center, Israel'}}}}