Vitamin D Status in Inflammatory Bowel Disease

NCT ID: NCT03496246

Last Updated: 2018-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-30

Study Completion Date

2019-06-30

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.

Conditions

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Vitamin D Deficiency Inflammatory Bowel Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It is a Clinical trial with three arms
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

serum total 25 hydroxycholecalciferol 25(OH) vitamin D

Intervention Type DIAGNOSTIC_TEST

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.

complete blood count (CBC)

Intervention Type DIAGNOSTIC_TEST

for measurement of hemoglobin level and white blood cell count percent of neutrophils ,lymphocytes and esoinphils

serum calcium level

Intervention Type DIAGNOSTIC_TEST

measurement of total calcium level after correction with albumin level as it is closely related to vitamin d with its effects on its level

erythrocyte sedimentation rate (ESR)

Intervention Type DIAGNOSTIC_TEST

it is an indicator of activity in inflammatory bowel disease

C-reactive protein (CRP)

Intervention Type DIAGNOSTIC_TEST

it is an indicator for increased possibility of infections

serum creatinine

Intervention Type DIAGNOSTIC_TEST

for assessment of renal function

serum albumin level

Intervention Type DIAGNOSTIC_TEST

for possibility of malabsorbtion in patients with inflammatory bowel disease

seum alanine aminotransferase

Intervention Type DIAGNOSTIC_TEST

for assessment of liver function

serum potassium level

Intervention Type DIAGNOSTIC_TEST

indicator for hypokalemia increased in patients with diarrhea as result of inflammatory bowel disease

serum phosphurus level

Intervention Type DIAGNOSTIC_TEST

measurement of phosphurus level as it is closely related to vitamin d with its effects on its level

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.

Group Type ACTIVE_COMPARATOR

serum total 25 hydroxycholecalciferol 25(OH) vitamin D

Intervention Type DIAGNOSTIC_TEST

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.

complete blood count (CBC)

Intervention Type DIAGNOSTIC_TEST

for measurement of hemoglobin level and white blood cell count percent of neutrophils ,lymphocytes and esoinphils

serum calcium level

Intervention Type DIAGNOSTIC_TEST

measurement of total calcium level after correction with albumin level as it is closely related to vitamin d with its effects on its level

erythrocyte sedimentation rate (ESR)

Intervention Type DIAGNOSTIC_TEST

it is an indicator of activity in inflammatory bowel disease

C-reactive protein (CRP)

Intervention Type DIAGNOSTIC_TEST

it is an indicator for increased possibility of infections

serum creatinine

Intervention Type DIAGNOSTIC_TEST

for assessment of renal function

serum albumin level

Intervention Type DIAGNOSTIC_TEST

for possibility of malabsorbtion in patients with inflammatory bowel disease

seum alanine aminotransferase

Intervention Type DIAGNOSTIC_TEST

for assessment of liver function

serum potassium level

Intervention Type DIAGNOSTIC_TEST

indicator for hypokalemia increased in patients with diarrhea as result of inflammatory bowel disease

serum phosphurus level

Intervention Type DIAGNOSTIC_TEST

measurement of phosphurus level as it is closely related to vitamin d with its effects on its level

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.

Group Type ACTIVE_COMPARATOR

serum total 25 hydroxycholecalciferol 25(OH) vitamin D

Intervention Type DIAGNOSTIC_TEST

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.

complete blood count (CBC)

Intervention Type DIAGNOSTIC_TEST

for measurement of hemoglobin level and white blood cell count percent of neutrophils ,lymphocytes and esoinphils

serum calcium level

Intervention Type DIAGNOSTIC_TEST

measurement of total calcium level after correction with albumin level as it is closely related to vitamin d with its effects on its level

erythrocyte sedimentation rate (ESR)

Intervention Type DIAGNOSTIC_TEST

it is an indicator of activity in inflammatory bowel disease

C-reactive protein (CRP)

Intervention Type DIAGNOSTIC_TEST

it is an indicator for increased possibility of infections

serum creatinine

Intervention Type DIAGNOSTIC_TEST

for assessment of renal function

serum albumin level

Intervention Type DIAGNOSTIC_TEST

for possibility of malabsorbtion in patients with inflammatory bowel disease

seum alanine aminotransferase

Intervention Type DIAGNOSTIC_TEST

for assessment of liver function

serum potassium level

Intervention Type DIAGNOSTIC_TEST

indicator for hypokalemia increased in patients with diarrhea as result of inflammatory bowel disease

serum phosphurus level

Intervention Type DIAGNOSTIC_TEST

measurement of phosphurus level as it is closely related to vitamin d with its effects on its level

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

complete blood count (CBC)

for measurement of hemoglobin level and white blood cell count percent of neutrophils ,lymphocytes and esoinphils

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

erythrocyte sedimentation rate (ESR)

it is an indicator of activity in inflammatory bowel disease

Intervention Type DIAGNOSTIC_TEST

C-reactive protein (CRP)

it is an indicator for increased possibility of infections

Intervention Type DIAGNOSTIC_TEST

serum creatinine

for assessment of renal function

Intervention Type DIAGNOSTIC_TEST

serum albumin level

for possibility of malabsorbtion in patients with inflammatory bowel disease

Intervention Type DIAGNOSTIC_TEST

seum alanine aminotransferase

for assessment of liver function

Intervention Type DIAGNOSTIC_TEST

serum potassium level

indicator for hypokalemia increased in patients with diarrhea as result of inflammatory bowel disease

Intervention Type DIAGNOSTIC_TEST

serum phosphurus level

measurement of phosphurus level as it is closely related to vitamin d with its effects on its level

Intervention Type DIAGNOSTIC_TEST

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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mohammed ragab

resident doctor at internal medicine department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mohammed Ragab Osman

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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Burisch J, Munkholm P. Inflammatory bowel disease epidemiology. Curr Opin Gastroenterol. 2013 Jul;29(4):357-62. doi: 10.1097/MOG.0b013e32836229fb.

Reference Type BACKGROUND
PMID: 23695429 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25204669 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24619280 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23751398 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24088707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28516265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21247315 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21910173 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21527593 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21646368 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15113361 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18200661 (View on PubMed)

Other Identifiers

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2929mroam

Identifier Type: -

Identifier Source: org_study_id

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