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Vitamin D Status in Inflammatory Bowel Disease (vdsinibd)

Primary Purpose

Vitamin D Deficiency, Inflammatory Bowel Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
serum total 25 hydroxycholecalciferol 25(OH) vitamin D
complete blood count (CBC)
serum calcium level
erythrocyte sedimentation rate (ESR)
C-reactive protein (CRP)
serum creatinine
serum albumin level
seum alanine aminotransferase
serum potassium level
serum phosphurus level
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vitamin D Deficiency

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Mohammed Ragab Osman

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Group C

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
April 1, 2018
Last Updated
April 5, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03496246
Brief Title
Vitamin D Status in Inflammatory Bowel Disease
Acronym
vdsinibd
Official Title
Vitamin D Status in Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2018 (Anticipated)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Inflammatory Bowel Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It is a Clinical trial with three arms
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm 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.
Arm Title
Group B
Arm Type
Active Comparator
Arm 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.
Arm Title
Group C
Arm Type
Active Comparator
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
serum total 25 hydroxycholecalciferol 25(OH) vitamin D
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
complete blood count (CBC)
Intervention Description
for measurement of hemoglobin level and white blood cell count percent of neutrophils ,lymphocytes and esoinphils
Intervention Type
Diagnostic Test
Intervention Name(s)
serum calcium level
Intervention Description
measurement of total calcium level after correction with albumin level as it is closely related to vitamin d with its effects on its level
Intervention Type
Diagnostic Test
Intervention Name(s)
erythrocyte sedimentation rate (ESR)
Intervention Description
it is an indicator of activity in inflammatory bowel disease
Intervention Type
Diagnostic Test
Intervention Name(s)
C-reactive protein (CRP)
Intervention Description
it is an indicator for increased possibility of infections
Intervention Type
Diagnostic Test
Intervention Name(s)
serum creatinine
Intervention Description
for assessment of renal function
Intervention Type
Diagnostic Test
Intervention Name(s)
serum albumin level
Intervention Description
for possibility of malabsorbtion in patients with inflammatory bowel disease
Intervention Type
Diagnostic Test
Intervention Name(s)
seum alanine aminotransferase
Intervention Description
for assessment of liver function
Intervention Type
Diagnostic Test
Intervention Name(s)
serum potassium level
Intervention Description
indicator for hypokalemia increased in patients with diarrhea as result of inflammatory bowel disease
Intervention Type
Diagnostic Test
Intervention Name(s)
serum phosphurus level
Intervention Description
measurement of phosphurus level as it is closely related to vitamin d with its effects on its level
Primary Outcome Measure Information:
Title
vitamin D deficency in Inflammatory Bowel Disease
Description
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.
Time Frame
one day
Title
vitamin D insufficiency in Inflammatory Bowel Disease
Description
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.
Time Frame
one day
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Mohammed Ragab Osman
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23695429
Citation
Burisch J, Munkholm P. Inflammatory bowel disease epidemiology. Curr Opin Gastroenterol. 2013 Jul;29(4):357-62. doi: 10.1097/MOG.0b013e32836229fb.
Results Reference
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PubMed Identifier
25204669
Citation
Ananthakrishnan AN. Environmental risk factors for inflammatory bowel diseases: a review. Dig Dis Sci. 2015 Feb;60(2):290-8. doi: 10.1007/s10620-014-3350-9. Epub 2014 Sep 10.
Results Reference
background
PubMed Identifier
24619280
Citation
Abraham BP, Prasad P, Malaty HM. Vitamin D deficiency and corticosteroid use are risk factors for low bone mineral density in inflammatory bowel disease patients. Dig Dis Sci. 2014 Aug;59(8):1878-84. doi: 10.1007/s10620-014-3102-x. Epub 2014 Mar 12.
Results Reference
background
PubMed Identifier
23751398
Citation
Ananthakrishnan AN, Cagan A, Gainer VS, Cai T, Cheng SC, Savova G, Chen P, Szolovits P, Xia Z, De Jager PL, Shaw SY, Churchill S, Karlson EW, Kohane I, Plenge RM, Murphy SN, Liao KP. Normalization of plasma 25-hydroxy vitamin D is associated with reduced risk of surgery in Crohn's disease. Inflamm Bowel Dis. 2013 Aug;19(9):1921-7. doi: 10.1097/MIB.0b013e3182902ad9.
Results Reference
background
PubMed Identifier
24088707
Citation
Zator ZA, Cantu SM, Konijeti GG, Nguyen DD, Sauk J, Yajnik V, Ananthakrishnan AN. Pretreatment 25-hydroxyvitamin D levels and durability of anti-tumor necrosis factor-alpha therapy in inflammatory bowel diseases. JPEN J Parenter Enteral Nutr. 2014 Mar-Apr;38(3):385-91. doi: 10.1177/0148607113504002. Epub 2013 Oct 2.
Results Reference
background
PubMed Identifier
28516265
Citation
Holick MF. The vitamin D deficiency pandemic: Approaches for diagnosis, treatment and prevention. Rev Endocr Metab Disord. 2017 Jun;18(2):153-165. doi: 10.1007/s11154-017-9424-1.
Results Reference
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PubMed Identifier
21247315
Citation
Rosen CJ. Clinical practice. Vitamin D insufficiency. N Engl J Med. 2011 Jan 20;364(3):248-54. doi: 10.1056/NEJMcp1009570. No abstract available.
Results Reference
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PubMed Identifier
21910173
Citation
Farraye FA, Nimitphong H, Stucchi A, Dendrinos K, Boulanger AB, Vijjeswarapu A, Tanennbaum A, Biancuzzo R, Chen TC, Holick MF. Use of a novel vitamin D bioavailability test demonstrates that vitamin D absorption is decreased in patients with quiescent Crohn's disease. Inflamm Bowel Dis. 2011 Oct;17(10):2116-21. doi: 10.1002/ibd.21595. Epub 2011 Jan 6.
Results Reference
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PubMed Identifier
21527593
Citation
Ulitsky A, Ananthakrishnan AN, Naik A, Skaros S, Zadvornova Y, Binion DG, Issa M. Vitamin D deficiency in patients with inflammatory bowel disease: association with disease activity and quality of life. JPEN J Parenter Enteral Nutr. 2011 May;35(3):308-16. doi: 10.1177/0148607110381267.
Results Reference
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PubMed Identifier
21646368
Citation
Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6. Erratum In: J Clin Endocrinol Metab. 2011 Dec;96(12):3908.
Results Reference
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PubMed Identifier
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Citation
Bernstein CN, Leslie WD. Review article: Osteoporosis and inflammatory bowel disease. Aliment Pharmacol Ther. 2004 May 1;19(9):941-52. doi: 10.1111/j.1365-2036.2004.01876.x.
Results Reference
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PubMed Identifier
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Citation
Shih DQ, Targan SR. Immunopathogenesis of inflammatory bowel disease. World J Gastroenterol. 2008 Jan 21;14(3):390-400. doi: 10.3748/wjg.14.390.
Results Reference
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Vitamin D Status in Inflammatory Bowel Disease

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