Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT01369667
Status:
COMPLETED
Last Update Posted:
2015-08-18
First Post:
2011-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vitamin D Supplementation in Adult Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-15', 'studyFirstSubmitDate': '2011-06-07', 'studyFirstSubmitQcDate': '2011-06-07', 'lastUpdatePostDateStruct': {'date': '2015-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Relapse: defined as a CDAI of 150 or more and an increase in CDAI of more than 70 compared with baseline during the 12 month follow-up period.', 'timeFrame': '12 Months'}]}, 'conditionsModule': {'conditions': ["Crohn's Disease"]}, 'referencesModule': {'references': [{'pmid': '30649836', 'type': 'DERIVED', 'citation': "O'Sullivan F, Raftery T, van Weele M, van Geffen J, McNamara D, O'Morain C, Mahmud N, Kelly D, Healy M, O'Sullivan M, Zgaga L. Sunshine is an Important Determinant of Vitamin D Status Even Among High-dose Supplement Users: Secondary Analysis of a Randomized Controlled Trial in Crohn's Disease Patients. Photochem Photobiol. 2019 Jul;95(4):1060-1067. doi: 10.1111/php.13086. Epub 2019 Mar 12."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether vitamin D supplementation is effective in the prevention of relapse in Crohn's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All patients must fulfill the clinical criteria for diagnosis of Crohn's disease.\n* Subjects must have inactive CD as defined by CDAI \\< 150\n* CRP \\</=10 mg/L.\n\nExclusion Criteria:\n\n* Pregnant and lactating women.\n* Known hypersensitivity to vitamin D.\n* Hypercalcaemia\n* Current supplemental intake of vitamin D3 \\>800 IU/D.\n* Diagnosis of any of the following: active tuberculosis, sarcoidosis, hyperparathyroidism, pseudohyperparathyroidism, renal failure or malignancy, active TB, sarcoidosis, lymphoma.\n* Participation in a concurrent clinical trial."}, 'identificationModule': {'nctId': 'NCT01369667', 'acronym': 'VITD-CD', 'briefTitle': "Vitamin D Supplementation in Adult Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Dublin, Trinity College'}, 'officialTitle': "Vitamin D and Immunomodulation: Effects in Crohn's Disease", 'orgStudyIdInfo': {'id': 'VITD/CD/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'vitamin D', 'description': 'Capsule, one taken daily', 'interventionNames': ['Dietary Supplement: Vitamin D3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Capsule, one taken daily', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['vitamin D']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dublin', 'country': 'Ireland', 'facility': "Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital,", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'overallOfficials': [{'name': "Maria O'Sullivan, PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TCD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Dublin, Trinity College', 'class': 'OTHER'}, 'collaborators': [{'name': 'Queen Mary University of London', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research dietitian', 'investigatorFullName': 'Tara Raftery', 'investigatorAffiliation': 'University of Dublin, Trinity College'}}}}