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Vitamin D Status in Inflammatory Bowel Disease (vdsinibd)

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ClinicalTrials.gov Identifier: NCT03496246
Recruitment Status : Unknown
Verified April 2018 by mohammed ragab, Assiut University.
Recruitment status was:  Enrolling by invitation
First Posted : April 12, 2018
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
mohammed ragab, 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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Inflammatory Bowel Diseases 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: It is a Clinical trial with three arms
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Vitamin D Status in Inflammatory Bowel Disease
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: Group A
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
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

Active Comparator: Group B
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
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

Active Comparator: Group C
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
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




Primary Outcome Measures :
  1. vitamin D deficency in Inflammatory Bowel Disease [ Time Frame: 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.

  2. vitamin D insufficiency in Inflammatory Bowel Disease [ Time Frame: 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 :
  1. 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 [ Time Frame: 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




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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496246


Locations
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Egypt
Mohammed Ragab Osman
Assiut, Egypt
Sponsors and Collaborators
Assiut University
Publications:

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Responsible Party: mohammed ragab, resident doctor at internal medicine department, Assiut University
ClinicalTrials.gov Identifier: NCT03496246    
Other Study ID Numbers: 2929mroam
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Vitamin D Deficiency
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Hydroxycholecalciferols
Alfacalcidol
Calcifediol
Calcium
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents