Vitamin D Status in Inflammatory Bowel Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vitamin D Status in Inflammatory Bowel Disease

Conditions
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Vitamin D Deficiency, Inflammatory Bowel Diseases

Intervention / Treatment
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* Diagnostic Test: serum total 25 hydroxycholecalciferol 25(OH) vitamin D
* Diagnostic Test: complete blood count (CBC)
* Diagnostic Test: serum calcium level
* Diagnostic Test: erythrocyte sedimentation rate (ESR)
* Diagnostic Test: C-reactive protein (CRP)
* Diagnostic Test: serum creatinine
* Diagnostic Test: serum albumin level
* Diagnostic Test: seum alanine aminotransferase
* Diagnostic Test: serum potassium level
* Diagnostic Test: serum phosphurus level


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It is a Clinical trial with three arms
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>patients with vitamin D deficiency are investigated for serum total 25 hydroxycholecalciferol 25(OH) vitamin D,complete blood count (CBC),serum calcium level ,serum phosphurus level,erythrocyte sedimentation rate (ESR),C-reactive protein (CRP),serum creatinine ,serum albumin level,seum alanine aminotransferase and serum potassium level. | Diagnostic Test: serum total 25 hydroxycholecalciferol 25(OH) vitamin D<br>* 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.<br>Diagnostic Test: complete blood count (CBC)<br>* for measurement of hemoglobin level and white blood cell count percent of neutrophils ,lymphocytes and esoinphils<br>Diagnostic Test: serum calcium level<br>* measurement of total calcium level after correction with albumin level as it is closely related to vitamin d with its effects on its level<br>Diagnostic Test: erythrocyte sedimentation rate (ESR)<br>* it is an indicator of activity in inflammatory bowel disease<br>Diagnostic Test: C-reactive protein (CRP)<br>* it is an indicator for increased possibility of infections<br>Diagnostic Test: serum creatinine<br>* for assessment of renal function<br>Diagnostic Test: serum albumin level<br>* for possibility of malabsorbtion in patients with inflammatory bowel disease<br>Diagnostic Test: seum alanine aminotransferase<br>* for assessment of liver function<br>Diagnostic Test: serum potassium level<br>* indicator for hypokalemia increased in patients with diarrhea as result of inflammatory bowel disease<br>Diagnostic Test: serum phosphurus level<br>* measurement of phosphurus level as it is closely related to vitamin d with its effects on its level<br>|
| Active Comparator: Group B<br>patients with vitamin D insufficiency are investigated for serum total 25 hydroxycholecalciferol 25(OH) vitamin D,complete blood count (CBC),serum calcium level ,serum phosphurus level,erythrocyte sedimentation rate (ESR),C-reactive protein (CRP),serum creatinine ,serum albumin level,seum alanine aminotransferase and serum potassium level. | Diagnostic Test: serum total 25 hydroxycholecalciferol 25(OH) vitamin D<br>* 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.<br>Diagnostic Test: complete blood count (CBC)<br>* for measurement of hemoglobin level and white blood cell count percent of neutrophils ,lymphocytes and esoinphils<br>Diagnostic Test: serum calcium level<br>* measurement of total calcium level after correction with albumin level as it is closely related to vitamin d with its effects on its level<br>Diagnostic Test: erythrocyte sedimentation rate (ESR)<br>* it is an indicator of activity in inflammatory bowel disease<br>Diagnostic Test: C-reactive protein (CRP)<br>* it is an indicator for increased possibility of infections<br>Diagnostic Test: serum creatinine<br>* for assessment of renal function<br>Diagnostic Test: serum albumin level<br>* for possibility of malabsorbtion in patients with inflammatory bowel disease<br>Diagnostic Test: seum alanine aminotransferase<br>* for assessment of liver function<br>Diagnostic Test: serum potassium level<br>* indicator for hypokalemia increased in patients with diarrhea as result of inflammatory bowel disease<br>Diagnostic Test: serum phosphurus level<br>* measurement of phosphurus level as it is closely related to vitamin d with its effects on its level<br>|
| Active Comparator: Group C<br>patients with normal vitamin D level normal are investigated for serum total 25 hydroxycholecalciferol 25(OH) vitamin D,complete blood count (CBC),serum calcium level ,serum phosphurus level,erythrocyte sedimentation rate (ESR),C-reactive protein (CRP),serum creatinine ,serum albumin level,seum alanine aminotransferase and serum potassium level. | Diagnostic Test: serum total 25 hydroxycholecalciferol 25(OH) vitamin D<br>* 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.<br>Diagnostic Test: complete blood count (CBC)<br>* for measurement of hemoglobin level and white blood cell count percent of neutrophils ,lymphocytes and esoinphils<br>Diagnostic Test: serum calcium level<br>* measurement of total calcium level after correction with albumin level as it is closely related to vitamin d with its effects on its level<br>Diagnostic Test: erythrocyte sedimentation rate (ESR)<br>* it is an indicator of activity in inflammatory bowel disease<br>Diagnostic Test: C-reactive protein (CRP)<br>* it is an indicator for increased possibility of infections<br>Diagnostic Test: serum creatinine<br>* for assessment of renal function<br>Diagnostic Test: serum albumin level<br>* for possibility of malabsorbtion in patients with inflammatory bowel disease<br>Diagnostic Test: seum alanine aminotransferase<br>* for assessment of liver function<br>Diagnostic Test: serum potassium level<br>* indicator for hypokalemia increased in patients with diarrhea as result of inflammatory bowel disease<br>Diagnostic Test: serum phosphurus level<br>* measurement of phosphurus level as it is closely related to vitamin d with its effects on its level<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vitamin D deficency in Inflammatory Bowel Disease | 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. | one day | 
| vitamin D insufficiency in Inflammatory Bowel Disease | 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. | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | one day |