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Not yet recruitingNCT07259603Updated Dec 2, 2025

Association Between Vitamin D Deficiency and Inflammatory Bowel Disease

An observational study in Inflammatory Bowel Diseases, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-02.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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

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Conditions studied

  • Inflammatory Bowel Diseases
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In context

Inflammatory Bowel Diseases

1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.

This study's planned enrollment of 100 is below the median of 139 across 645 observational studies indexed under Inflammatory Bowel Diseases.

Browse Inflammatory Bowel Diseases studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • Current vitamin D supplementation(>1000IU/day)

    • History of malabsorption syndromes (e.g.,celiac disease)
    • Chronic kidney or liver disease
    • Pregnancy
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testSerum 25(OH)D (Vitamin D3), C- reactive protein, Erthrocyte sedimentation rate

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

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What researchers measure

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)

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005. PubMed 17653185 ↗
  • 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. PubMed 22001864 ↗
  • 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. PubMed 15585793 ↗
  • 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. PubMed 16563470 ↗
  • 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. PubMed 24236989 ↗
  • 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. PubMed 31067701 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07259603
Lead sponsor
Assiut University
Responsible party
Ahmed Mahmoud Hamed Gadelrab (principal investigator, Assiut University) — Principal investigator
First posted
Dec 2, 2025
Start date
Jan 2026 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Dec 2, 2025

Study contacts

Noor el-Deen A. Mohamed, Professor of internal medicine
Contact
noorelhefny@aun.edu.eg
01005035180
Ahmed A. Maghraby, Lecturer of internal medicine
Contact
Dr-magraby@aun.edu.eg
01122871357

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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