Vitamin D Deficiency, Inflammatory Bowel Diseases
Conditions
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.
Interventions
DIAGNOSTIC_TESTserum total 25 hydroxycholecalciferol 25(OH) vitamin D
Quantitative measurement of serum total 25(OH) vitamin D by ELISA. Fasting (6-8 hours), venous blood samples(10ml) are collected from participants in the morning and after centrifugation, the serum are preserved in the deep freezer at -20 c. Serum levels will be determined by using commercially available kits.
DIAGNOSTIC_TESTcomplete blood count (CBC)
for measurement of hemoglobin level and white blood cell count percent of neutrophils ,lymphocytes and esoinphils
DIAGNOSTIC_TESTserum calcium level
measurement of total calcium level after correction with albumin level as it is closely related to vitamin d with its effects on its level
DIAGNOSTIC_TESTerythrocyte sedimentation rate (ESR)
it is an indicator of activity in inflammatory bowel disease
DIAGNOSTIC_TESTC-reactive protein (CRP)
it is an indicator for increased possibility of infections
DIAGNOSTIC_TESTserum creatinine
for assessment of renal function
DIAGNOSTIC_TESTserum albumin level
for possibility of malabsorbtion in patients with inflammatory bowel disease
DIAGNOSTIC_TESTseum alanine aminotransferase
for assessment of liver function
DIAGNOSTIC_TESTserum potassium level
indicator for hypokalemia increased in patients with diarrhea as result of inflammatory bowel disease
DIAGNOSTIC_TESTserum phosphurus level
measurement of phosphurus level as it is closely related to vitamin d with its effects on its level
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
It is a Clinical trial with three arms
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Any patient with Inflammatory Bowel Disease (either ulcerative colitis or crohns disease ) patients diagnosed through clinical evaluation ,laboratory ,colonoscopic and histopathological studies.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed