Trial of High Dose Vitamin D in Patient's With Crohn's Disease
NCT ID: NCT02208310
Last Updated: 2017-10-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
11 participants
INTERVENTIONAL
2015-04-30
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Low Dose Vitamin D
Patients will be given 400 IU cholecalciferol once daily for 30 days. \<-THIS IS THE Active Comparator Intervention. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.
Cholecalciferol 400 IU
Cholecalciferol 400 IU po daily
High Dose Vitamin D
Patients will be given cholecalciferol 10,000 IU daily for 30 days. \<-THIS IS THE INTERVENTION. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if \<50 ng/ml, a 30 day course will be administered.
Cholecalciferol 10,000 IU
Cholecalciferol 10,000 IU po daily
Interventions
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Cholecalciferol 10,000 IU
Cholecalciferol 10,000 IU po daily
Cholecalciferol 400 IU
Cholecalciferol 400 IU po daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \>= 18 and \<75
* Vitamin D deficiency or insufficiency (serum 25-hydroxyvitamin D \< 30ng/ml)
Exclusion Criteria
* CD-related surgery in the last 6 months
* CD-related hospitalization in the last 4 weeks
* Pregnancy, intended pregnancy during the study period or nursing
* Serum calcium \>10.2 mg/dL
* History of primary sclerosing cholangitis
* History of undergoing an ileal pouch-anal anastomosis
* Current active perianal disease
* History of nephrolithiasis in the past 2 years
* Anticipated change in therapy in the next 30 days (steroids, biologic initiation)
* modified Harvey-Bradshaw Index of 10 or more
* History of decreased renal function (glomerular filtration rate \<30ml/min based on MDRD) or polycystic kidney disease
* History of sarcoidosis
* History of hyperparathyroidism
* Any other chronic condition that may preclude high doses of Vitamin D such as lymphoma
* Concurrent use of hydrochlorothiazide, phenytoin, phenobarbital, carbamazepine or primidone
* Osteoporosis
18 Years
75 Years
ALL
No
Sponsors
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Crohn's and Colitis Foundation
OTHER
University of Michigan
OTHER
Responsible Party
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Peter Higgins
Assistant Professor
Principal Investigators
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Peter D. Higgins, MD, PhD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Shail M Govani, M.D., M.Sc.
Role: STUDY_DIRECTOR
University of Michigan
Hans Herfarth, MD, PhD
Role: STUDY_DIRECTOR
University of North Carolina
Locations
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Indiana University
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Michigan
Ann Arbor, Michigan, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Countries
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References
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Jorgensen SP, Agnholt J, Glerup H, Lyhne S, Villadsen GE, Hvas CL, Bartels LE, Kelsen J, Christensen LA, Dahlerup JF. Clinical trial: vitamin D3 treatment in Crohn's disease - a randomized double-blind placebo-controlled study. Aliment Pharmacol Ther. 2010 Aug;32(3):377-83. doi: 10.1111/j.1365-2036.2010.04355.x. Epub 2010 May 11.
Khalili H, Huang ES, Ananthakrishnan AN, Higuchi L, Richter JM, Fuchs CS, Chan AT. Geographical variation and incidence of inflammatory bowel disease among US women. Gut. 2012 Dec;61(12):1686-92. doi: 10.1136/gutjnl-2011-301574. Epub 2012 Jan 11.
Cantorna MT, Munsick C, Bemiss C, Mahon BD. 1,25-Dihydroxycholecalciferol prevents and ameliorates symptoms of experimental murine inflammatory bowel disease. J Nutr. 2000 Nov;130(11):2648-52. doi: 10.1093/jn/130.11.2648.
Ananthakrishnan AN, Khalili H, Higuchi LM, Bao Y, Korzenik JR, Giovannucci EL, Richter JM, Fuchs CS, Chan AT. Higher predicted vitamin D status is associated with reduced risk of Crohn's disease. Gastroenterology. 2012 Mar;142(3):482-9. doi: 10.1053/j.gastro.2011.11.040. Epub 2011 Dec 9.
Other Identifiers
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CCFA-329225
Identifier Type: -
Identifier Source: org_study_id