NCT03496246

Vitamin D Status in Inflammatory Bowel Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vitamin D Deficiency
• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	serum 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_TEST	complete blood count (CBC)	for measurement of hemoglobin level and white blood cell count percent of neutrophils ,lymphocytes and esoinphils
DIAGNOSTIC_TEST	serum 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_TEST	erythrocyte sedimentation rate (ESR)	it is an indicator of activity in inflammatory bowel disease
DIAGNOSTIC_TEST	C-reactive protein (CRP)	it is an indicator for increased possibility of infections
DIAGNOSTIC_TEST	serum creatinine	for assessment of renal function
DIAGNOSTIC_TEST	serum albumin level	for possibility of malabsorbtion in patients with inflammatory bowel disease
DIAGNOSTIC_TEST	seum alanine aminotransferase	for assessment of liver function
DIAGNOSTIC_TEST	serum potassium level	indicator for hypokalemia increased in patients with diarrhea as result of inflammatory bowel disease
DIAGNOSTIC_TEST	serum phosphurus level	measurement of phosphurus level as it is closely related to vitamin d with its effects on its level

Timeline

• Start date: 2018-04-01
• Primary completion: 2019-04-01
• Completion: 2019-06-01
• First posted: 2018-04-12
• Last updated: 2018-04-12

Locations

1 site across 1 country: Egypt