Inflammatory Bowel DiseasesNCT07259603
Association Between Vitamin D Deficiency and Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Serum 25(OH)D (Vitamin D3), C- reactive protein, Erthrocyte sedimentation rate
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Current vitamin D supplementation(>1000IU/day)
- History of malabsorption syndromes (e.g.,celiac disease)
- Chronic kidney or liver disease
- Pregnancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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
- Being tested
- Serum 25(OH)D (Vitamin D3), C- reactive protein, Erthrocyte sedimentation rate
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum 25(OH)D (Vitamin D3), C- reactive protein, Erthrocyte sedimentation rateDiagnostic test
Serum 25(OH)D (Vitamin D3), C- reactive protein, Erthrocyte sedimentation rate are evaluated to assess vitamin D deficiency and IBD activity
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Serum 25(OH)D (Vitamin D3), C- reactive protein, Erthrocyte sedimentation rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Recent vitamin D and disease activity assessment (within 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Hamed Gadelrab, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259603
- Sponsor's protocol ID
- ADIBD
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 17653185Molodecky 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 22001864Cantorna 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 15585793Cantorna 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 16563470Mouli 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 24236989Fletcher 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Vitamin D Deficiency and Disease Activity in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT07259603
- Acronym / sponsor ID
- ADIBD
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients diagnosed with Crohn's disease (CD) and ulcerative colitis (UC) | – | Diagnostic Test: Serum 25(OH)D (Vitamin D3), C- reactive protein, Erthrocyte sedimentation rateAdults 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- Current vitamin D supplementation(>1000IU/day)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum 25(OH)D (Vitamin D3), C- reactive protein, Erthrocyte sedimentation rateSerum 25(OH)D (Vitamin D3), C- reactive protein, Erthrocyte sedimentation rate are evaluated to assess vitamin D deficiency and IBD activity | Diagnostic test | patients diagnosed with Crohn's disease (CD) and ulcerative colitis (UC) |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Background: PubMed 17653185Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005.
- Background: PubMed 22001864Molodecky 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.
- Background: PubMed 15585793Cantorna 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.
- Background: PubMed 16563470Cantorna 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.
- Background: PubMed 24236989Mouli 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.
- Background: PubMed 31067701Fletcher 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noor el-Deen A. Mohamed, Professor of internal medicine (01005035180, noorelhefny@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of vitamin D deficiency in patients with active inflammatory bowel disease (time frame: Recent vitamin D and disease activity assessment (within 1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07259603, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.