Vitamin D Status in Inflammatory Bowel Disease
vdsinibd
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2018
CompletedStudy Start
First participant enrolled
April 1, 2018
CompletedFirst Posted
Study publicly available on registry
April 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedApril 12, 2018
April 1, 2018
1 year
April 1, 2018
April 5, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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.
one day
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.
one day
Secondary Outcomes (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
one day
Study Arms (3)
Group A
ACTIVE COMPARATORpatients 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 B
ACTIVE COMPARATORpatients 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 C
ACTIVE COMPARATORpatients 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.
Interventions
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.
for measurement of hemoglobin level and white blood cell count percent of neutrophils ,lymphocytes and esoinphils
measurement of total calcium level after correction with albumin level as it is closely related to vitamin d with its effects on its level
it is an indicator of activity in inflammatory bowel disease
it is an indicator for increased possibility of infections
for possibility of malabsorbtion in patients with inflammatory bowel disease
indicator for hypokalemia increased in patients with diarrhea as result of inflammatory bowel disease
measurement of phosphurus level as it is closely related to vitamin d with its effects on its level
Eligibility Criteria
You may qualify if:
- Any patient with Inflammatory Bowel Disease (either ulcerative colitis or crohns disease ) patients diagnosed through clinical evaluation ,laboratory ,colonoscopic and histopathological studies.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mohammed Ragab Osman
Asyut, Egypt
Related Publications (12)
Burisch J, Munkholm P. Inflammatory bowel disease epidemiology. Curr Opin Gastroenterol. 2013 Jul;29(4):357-62. doi: 10.1097/MOG.0b013e32836229fb.
PMID: 23695429BACKGROUNDAnanthakrishnan 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.
PMID: 25204669BACKGROUNDAbraham 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.
PMID: 24619280BACKGROUNDAnanthakrishnan 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.
PMID: 23751398BACKGROUNDZator 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.
PMID: 24088707BACKGROUNDHolick 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.
PMID: 28516265BACKGROUNDRosen CJ. Clinical practice. Vitamin D insufficiency. N Engl J Med. 2011 Jan 20;364(3):248-54. doi: 10.1056/NEJMcp1009570. No abstract available.
PMID: 21247315BACKGROUNDFarraye 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.
PMID: 21910173BACKGROUNDUlitsky 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.
PMID: 21527593BACKGROUNDHolick 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.
PMID: 21646368BACKGROUNDBernstein 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.
PMID: 15113361BACKGROUNDShih DQ, Targan SR. Immunopathogenesis of inflammatory bowel disease. World J Gastroenterol. 2008 Jan 21;14(3):390-400. doi: 10.3748/wjg.14.390.
PMID: 18200661BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident doctor at internal medicine department
Study Record Dates
First Submitted
April 1, 2018
First Posted
April 12, 2018
Study Start
April 1, 2018
Primary Completion
April 1, 2019
Study Completion
June 1, 2019
Last Updated
April 12, 2018
Record last verified: 2018-04