Vitamin D Status in Inflammatory Bowel Disease
- Conditions
- Inflammatory Bowel DiseasesVitamin D Deficiency
- Registration Number
- NCT03496246
- Lead Sponsor
- Assiut University
- Brief Summary
Inflammatory bowel disease (IBD), comprising crohn's disease (CD) and ulcerative colitis (UC), is a a chronic, relapsing-remitting systemic disease. Vitamin D is a secosteroid hormone that possesses immunomodulatory properties and has been demonstrated to potentially influence inflammatory bowel disease (IBD) pathogenesis and activity.
- Detailed Description
Inflammatory bowel disease (IBD), comprising crohn's disease (CD) and ulcerative colitis (UC), is a a chronic, relapsing-remitting systemic disease and it is increasing sharply with rapidly increasing proportion in developing countries., and the common medications are not effective for most patients.The key underlying pathogenic mechanisms for both diseases is a dysregulated host immune response to commensal intestinal flora in genetically susceptible individuals.Vitamin D is a fat-soluble vitamin, a secosteroid hormone whose active form, calcitriol or 1,25-dihydroxyvitaminD3 (1,25(OH)2D3) plays important roles in immune regulation, particularly involving the innate immune system, cell differentiation and intercellular adhesion, promotes the production of anti-microbial peptides, including β-defensins and cathelicidins, the shift towards Th2 immune responses, and regulates autophagy and epithelial barrier integrity.The relationship between vitamin D deficiency and IBD is bidirectional that vit D with its immunomodulatory effects influence IBD pathogenesis and activity and IBD itself can lead to vitamin D deficiency.Vitamin D deficiency has associated with increased IBD activity scores, lower quality-of-life, an increased risk of IBD-related surgery and increased hospitalizations.\[4\]. Vitamin D downregulate powerful proinflammatory cytokines, such as TNF, which enhance the durability of anti-TNF therapy in IBD and its deficency has been found to be associated with earlier cessation of anti-TNFα therapy( loss of response to biologic therapy.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- Any patient with Inflammatory Bowel Disease (either ulcerative colitis or crohns disease ) patients diagnosed through clinical evaluation ,laboratory ,colonoscopic and histopathological studies.
- patients known to have malignancy, or metabolic disease associated with vitamin D and calcium abnormalities e.g. hyperparathyroidism and history of vitamin D supplementations.
- patients with known biliary disease, chronic liver and kidney diseases.
- Patients with a mal-absorption syndrome other than IBD.
- Pregnant or lactating patients.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method vitamin D deficency in Inflammatory Bowel Disease one day serum total 25(OH) vitamin D is measured in patients with Inflammatory Bowel Disease (either ulcerative colitis or crohns disease) by Quantitative measurement by ELISA with Fasting (6-8 hours), venous blood samples will be collected from participants in the morning. Serum 25(OH)D levels of less than 20 ng/mL indicate vitamin D deficiency.
vitamin D insufficiency in Inflammatory Bowel Disease one day by Quantitative measurement of serum total 25(OH) vitamin D by ELISA with Fasting (6-8 hours), venous blood samples will be collected from participants in the morning. Serum 25(OH)D levels between 21 and 29 ng/mL indicate vitamin D insufficiency.
- Secondary Outcome Measures
Name Time Method the severity of Inflammatory Bowel Disease with its relation to vitamin D level the severity is detected by a composite clinical and biomarker index called the Seo index one day severity of Inflammatory Bowel Disease is detected by a composite clinical and biomarker index that combines the clinical symptoms including fever, bleeding and stool frequency with biomarkers including C-reactive protein (CRP), erythrocyte sedimentation rate(ESR),complete blood count (CBC), serum electrolytes.
we will investigate the relation between vitamin D deficiency and severity of Inflammatory Bowel Disease
Trial Locations
- Locations (1)
Mohammed Ragab Osman
🇪🇬Assiut, Egypt
Mohammed Ragab Osman🇪🇬Assiut, Egypt