Study Results
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Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2018-04-30
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
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.
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.
complete blood count (CBC)
for measurement of hemoglobin level and white blood cell count percent of neutrophils ,lymphocytes and esoinphils
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
erythrocyte sedimentation rate (ESR)
it is an indicator of activity in inflammatory bowel disease
C-reactive protein (CRP)
it is an indicator for increased possibility of infections
serum creatinine
for assessment of renal function
serum albumin level
for possibility of malabsorbtion in patients with inflammatory bowel disease
seum alanine aminotransferase
for assessment of liver function
serum potassium level
indicator for hypokalemia increased in patients with diarrhea as result of inflammatory bowel disease
serum phosphurus level
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.
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.
complete blood count (CBC)
for measurement of hemoglobin level and white blood cell count percent of neutrophils ,lymphocytes and esoinphils
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
erythrocyte sedimentation rate (ESR)
it is an indicator of activity in inflammatory bowel disease
C-reactive protein (CRP)
it is an indicator for increased possibility of infections
serum creatinine
for assessment of renal function
serum albumin level
for possibility of malabsorbtion in patients with inflammatory bowel disease
seum alanine aminotransferase
for assessment of liver function
serum potassium level
indicator for hypokalemia increased in patients with diarrhea as result of inflammatory bowel disease
serum phosphurus level
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.
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.
complete blood count (CBC)
for measurement of hemoglobin level and white blood cell count percent of neutrophils ,lymphocytes and esoinphils
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
erythrocyte sedimentation rate (ESR)
it is an indicator of activity in inflammatory bowel disease
C-reactive protein (CRP)
it is an indicator for increased possibility of infections
serum creatinine
for assessment of renal function
serum albumin level
for possibility of malabsorbtion in patients with inflammatory bowel disease
seum alanine aminotransferase
for assessment of liver function
serum potassium level
indicator for hypokalemia increased in patients with diarrhea as result of inflammatory bowel disease
serum phosphurus level
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.
complete blood count (CBC)
for measurement of hemoglobin level and white blood cell count percent of neutrophils ,lymphocytes and esoinphils
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
erythrocyte sedimentation rate (ESR)
it is an indicator of activity in inflammatory bowel disease
C-reactive protein (CRP)
it is an indicator for increased possibility of infections
serum creatinine
for assessment of renal function
serum albumin level
for possibility of malabsorbtion in patients with inflammatory bowel disease
seum alanine aminotransferase
for assessment of liver function
serum potassium level
indicator for hypokalemia increased in patients with diarrhea as result of inflammatory bowel disease
serum phosphurus level
measurement of phosphurus level as it is closely related to vitamin d with its effects on its level
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* patients with known biliary disease, chronic liver and kidney diseases.
* Patients with a mal-absorption syndrome other than IBD.
* Pregnant or lactating patients.
20 Years
60 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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mohammed ragab
resident doctor at internal medicine department
Locations
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Mohammed Ragab Osman
Asyut, , Egypt
Countries
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2929mroam
Identifier Type: -
Identifier Source: org_study_id
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