Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2025-12-24 @ 7:37 PM
Study NCT ID:
NCT07259603
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-11-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Association Between Vitamin D Deficiency and Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-30', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2025-11-30', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of vitamin D deficiency in patients with active inflammatory bowel disease', 'timeFrame': 'Recent vitamin D and disease activity assessment (within 1 month)', 'description': 'This will be done by measuring the vitamin D level in the serum of patients with active inflammatory bowel diseases (in nanograms/ milliliter)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases']}, 'referencesModule': {'references': [{'pmid': '17653185', 'type': 'BACKGROUND', 'citation': 'Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005.'}, {'pmid': '22001864', 'type': 'BACKGROUND', 'citation': 'Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, Benchimol EI, Panaccione R, Ghosh S, Barkema HW, Kaplan GG. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012 Jan;142(1):46-54.e42; quiz e30. doi: 10.1053/j.gastro.2011.10.001. Epub 2011 Oct 14.'}, {'pmid': '15585793', 'type': 'BACKGROUND', 'citation': 'Cantorna MT, Zhu Y, Froicu M, Wittke A. Vitamin D status, 1,25-dihydroxyvitamin D3, and the immune system. Am J Clin Nutr. 2004 Dec;80(6 Suppl):1717S-20S. doi: 10.1093/ajcn/80.6.1717S.'}, {'pmid': '16563470', 'type': 'BACKGROUND', 'citation': 'Cantorna MT. Vitamin D and its role in immunology: multiple sclerosis, and inflammatory bowel disease. Prog Biophys Mol Biol. 2006 Sep;92(1):60-4. doi: 10.1016/j.pbiomolbio.2006.02.020. Epub 2006 Feb 28.'}, {'pmid': '24236989', 'type': 'BACKGROUND', 'citation': 'Mouli VP, Ananthakrishnan AN. Review article: vitamin D and inflammatory bowel diseases. Aliment Pharmacol Ther. 2014 Jan;39(2):125-36. doi: 10.1111/apt.12553. Epub 2013 Nov 17.'}, {'pmid': '31067701', 'type': 'BACKGROUND', 'citation': 'Fletcher J, Cooper SC, Ghosh S, Hewison M. The Role of Vitamin D in Inflammatory Bowel Disease: Mechanism to Management. Nutrients. 2019 May 7;11(5):1019. doi: 10.3390/nu11051019.'}]}, 'descriptionModule': {'briefSummary': "Crohn's disease (CD) and ulcerative colitis (UC) are two major types of inflammatory bowel disease (IBD) that are identified by different clinical, endoscopic, pathological, and radiologic diagnostic methods.\n\nIn the past few years, the incidence of inflammatory bowel disease has been increasing worldwide, with the incidence of UC being higher than that of CD.\n\nVitamin D is a fat-soluble vitamin that is produced in the skin by a UV-dependent reactionand then hydroxylated by the kidneys and liver, and is converted to its active form, 1,25-dihydroxyvitamin D.\n\nVitamin D deficiency is common throughout the world and its deficiency rates ranging from 30 to 50% have been reported.\n\nSeveral studies have shown the role of vitamin D as a regulator of the immune system and its inhibitory function incellular immunity and production of pro-inflammatory cytokines that play a major role in autoimmune diseases.\n\nIn some human studies, the link between vitamin D levels and the disease severity of IBD has been shown, but it is not clear whether lack of vitamin D is the cause or consequence.\n\nIn this study, we aimed to investigate the relationship between inflammatory bowel disease and itsflare-up with serum levels of vitamin D"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "* Adults aged ≥18 years\n* Diagnosed with crohn's and ulcerative colitis\n* Regular follow-up as an outpatient in the IBD clinic at Al-RAGHI hospital Assuit university\n* Recent vitamin D and disease activity assessment (within 1 month)\n* Sample Size Calculation:\n\nAssuming an expected prevalence of vitamin D deficiency in IBD patients around 50%, a sample size of n = 100-150 will give adequate power (80%) to detect significant correlations (p \\< 0.05) between vitamin D levels and disease activity indices.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Diagnosed with crohn's and ulcerative colitis\n* Regular follow-up in IBD clinic\n* Recent vitamin D and disease activity assessment (within 1 month)\n\nExclusion Criteria:\n\n* Current vitamin D supplementation(\\>1000IU/day)\n\n * History of malabsorption syndromes (e.g.,celiac disease)\n * Chronic kidney or liver disease\n * Pregnancy"}, 'identificationModule': {'nctId': 'NCT07259603', 'briefTitle': 'Association Between Vitamin D Deficiency and Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Association Between Vitamin D Deficiency and Disease Activity in Patients With Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'ADIBD'}}, 'armsInterventionsModule': {'armGroups': [{'label': "patients diagnosed with Crohn's disease (CD) and ulcerative colitis (UC)", 'description': "Adults aged ≥18 years, diagnosed with Crohn's disease (CD) and ulcerative colitis (UC), and on regular follow-up in the IBD clinic, are followed up for recent vitamin D and disease activity assessment (within 1 month)", 'interventionNames': ['Diagnostic Test: Serum 25(OH)D (Vitamin D3), C- reactive protein, Erthrocyte sedimentation rate']}], 'interventions': [{'name': 'Serum 25(OH)D (Vitamin D3), C- reactive protein, Erthrocyte sedimentation rate', 'type': 'DIAGNOSTIC_TEST', 'description': 'Serum 25(OH)D (Vitamin D3), C- reactive protein, Erthrocyte sedimentation rate are evaluated to assess vitamin D deficiency and IBD activity', 'armGroupLabels': ["patients diagnosed with Crohn's disease (CD) and ulcerative colitis (UC)"]}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Noor el-Deen A. Mohamed, Professor of internal medicine', 'role': 'CONTACT', 'email': 'noorelhefny@aun.edu.eg', 'phone': '01005035180'}, {'name': 'Ahmed A. Maghraby, Lecturer of internal medicine', 'role': 'CONTACT', 'email': 'Dr-magraby@aun.edu.eg', 'phone': '01122871357'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Ahmed Mahmoud Hamed Gadelrab', 'investigatorAffiliation': 'Assiut University'}}}}