Vitamin D Status in Inflammatory Bowel Disease (vdsinibd)

Assiut University

Status

Unknown

Conditions

Vitamin D Deficiency

Inflammatory Bowel Diseases

Treatments

Diagnostic Test: serum albumin level

Diagnostic Test: serum phosphurus level

Diagnostic Test: erythrocyte sedimentation rate (ESR)

Diagnostic Test: seum alanine aminotransferase

Diagnostic Test: complete blood count (CBC)

Diagnostic Test: serum calcium level

Diagnostic Test: serum potassium level

Diagnostic Test: serum total 25 hydroxycholecalciferol 25(OH) vitamin D

Diagnostic Test: serum creatinine

Diagnostic Test: C-reactive protein (CRP)

Study type

Interventional

Funder types

Other

Identifiers

NCT03496246

2929mroam

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 3 patient groups

Group A

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: serum phosphurus level

Diagnostic Test: serum potassium level

Diagnostic Test: serum total 25 hydroxycholecalciferol 25(OH) vitamin D

Diagnostic Test: serum calcium level

Diagnostic Test: erythrocyte sedimentation rate (ESR)

Diagnostic Test: serum creatinine

Diagnostic Test: serum albumin level

Diagnostic Test: C-reactive protein (CRP)

Diagnostic Test: complete blood count (CBC)

Diagnostic Test: seum alanine aminotransferase

Group B

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: serum phosphurus level

Diagnostic Test: serum potassium level

Diagnostic Test: serum total 25 hydroxycholecalciferol 25(OH) vitamin D

Diagnostic Test: serum calcium level

Diagnostic Test: erythrocyte sedimentation rate (ESR)

Diagnostic Test: serum creatinine

Diagnostic Test: serum albumin level

Diagnostic Test: C-reactive protein (CRP)

Diagnostic Test: complete blood count (CBC)

Diagnostic Test: seum alanine aminotransferase

Group C

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: serum phosphurus level

Diagnostic Test: serum potassium level

Diagnostic Test: serum total 25 hydroxycholecalciferol 25(OH) vitamin D

Diagnostic Test: serum calcium level

Diagnostic Test: erythrocyte sedimentation rate (ESR)

Diagnostic Test: serum creatinine

Diagnostic Test: serum albumin level

Diagnostic Test: C-reactive protein (CRP)

Diagnostic Test: complete blood count (CBC)

Diagnostic Test: seum alanine aminotransferase