Association Between Vitamin D Deficiency and Inflammatory Bowel Disease

November 30, 2025 updated by: Ahmed Mahmoud Hamed Gadelrab, Assiut University

Association Between Vitamin D Deficiency and Disease Activity in Patients With Inflammatory Bowel Disease

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Noor el-Deen A. Mohamed, Professor of internal medicine
  • Phone Number: 01005035180
  • Email: noorelhefny@aun.edu.eg

Study Contact Backup

  • Name: Ahmed A. Maghraby, Lecturer of internal medicine
  • Phone Number: 01122871357
  • Email: Dr-magraby@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of vitamin D deficiency in patients with active inflammatory bowel disease
Time Frame: Recent vitamin D and disease activity assessment (within 1 month)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 30, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 30, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADIBD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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