Association Between Vitamin D Deficiency and Inflammatory Bowel Disease

NCT07259603 | Not Yet Recruiting

• 1 other identifier: ADIBD
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. In 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. Vitamin 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. Vitamin D deficiency is common throughout the world and its deficiency rates ranging from 30 to 50% have been reported. Several 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. In 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. In this study, we aimed to investigate the relationship between inflammatory bowel disease and itsflare-up with serum levels of vitamin D

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Prevalence of vitamin D deficiency in patients with active inflammatory bowel disease

  This will be done by measuring the vitamin D level in the serum of patients with active inflammatory bowel diseases (in nanograms/ milliliter)

  Recent vitamin D and disease activity assessment (within 1 month)

Study Arms (1)

patients diagnosed with Crohn's disease (CD) and ulcerative colitis (UC)

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)

Diagnostic Test: Serum 25(OH)D (Vitamin D3), C- reactive protein, Erthrocyte sedimentation rate

Interventions

Serum 25(OH)D (Vitamin D3), C- reactive protein, Erthrocyte sedimentation rate DIAGNOSTIC_TEST

Serum 25(OH)D (Vitamin D3), C- reactive protein, Erthrocyte sedimentation rate are evaluated to assess vitamin D deficiency and IBD activity

patients diagnosed with Crohn's disease (CD) and ulcerative colitis (UC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Adults aged ≥18 years * Diagnosed with crohn's and ulcerative colitis * Regular follow-up as an outpatient in the IBD clinic at Al-RAGHI hospital Assuit university * Recent vitamin D and disease activity assessment (within 1 month) * Sample Size Calculation: Assuming 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.

You may qualify if:

• Adults aged ≥18 years
• Diagnosed with crohn's and ulcerative colitis
• Regular follow-up in IBD clinic
• Recent vitamin D and disease activity assessment (within 1 month)

You may not qualify if:

• Current vitamin D supplementation(\>1000IU/day)
• History of malabsorption syndromes (e.g.,celiac disease)
• Chronic kidney or liver disease
• Pregnancy

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005.

  PMID: 17653185 BACKGROUND

• 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: 22001864 BACKGROUND

• 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: 15585793 BACKGROUND

• 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: 16563470 BACKGROUND

• 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: 24236989 BACKGROUND

• 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.

  PMID: 31067701 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Noor el-Deen A. Mohamed, Professor of internal medicine

CONTACT

01005035180; noorelhefny@aun.edu.eg

Ahmed A. Maghraby, Lecturer of internal medicine

CONTACT

01122871357; Dr-magraby@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 2, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share