NCT02208310|TerminatedPhase 4Results
Study Stopped
Unable to enroll at rate anticipated, insufft low vitamin D in clin rem @ 5 sites
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Unable to enroll at rate anticipated, insufft low vitamin D in clin rem @ 5 sites
RODIN-CD
A Randomized Controlled Trial of High-Dose Vitamin D in Crohn's Disease
Sponsor study identifier
interventional
11
1 country
4
Study Start
April 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2016
Actual (reported)Study Completion
April 2016
Actual (reported)Crohn's disease is more common in areas of the world with less sunlight exposure. Sunlight is a major source of vitamin D. There is some research to suggest that patient's with higher vitamin D levels are less likely to undergo surgeries and have better control of their disease. We intend to study the effects of high dose vitamin D supplementation in patients with vitamin D deficiency and Crohn's disease. We hypothesize that patients given high doses will have less hospitalizations, surgeries, steroid use.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2014
Actual (reported)August 5, 2014
Actual (reported)April 2015
Date type not reportedThis date has not been verified as actual or estimated.
April 2016
Actual (reported)April 2016
Actual (reported)October 6, 2017
Actual (reported)Composite Endpoint: Number of Participants With (Any of) a CD-related Hospitalization, CD-related Surgery, CD-related ER Visits and Steroid Prescriptions
Composite endpoint of (any of) Crohn's disease(CD)-related hospitalizations, CD-related surgeries, CD-related ER visits, or steroid prescriptions. Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.
Day 180
Hypercalcemia
Hypercalcemia is presented as number of participants with Calcium \>10.8 mg/dl Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.
Day 180
Incidence of Nephrolithiasis
Incidence of nephrolithiasis associated with hypercalcemia (\>10.8mg/dl) documented by imaging Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.
Day 180
Crohn's Related Hospitalizations
Day 180
Steroid Prescription Given (Dichotomous 0/1)
Day 180
Crohn's Related Surgeries (Dichotomous 0/1 Per Subject)
Day 180
Change in Modified Harvey-Bradshaw Index (HBI Without Examination)
Day 180
Change in C-reactive Protein
Day 180
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.
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 po daily
Cholecalciferol 400 IU po daily
Indiana University
Indianapolis, Indiana, 46001, United States
University of Iowa
Iowa City, Iowa, 55240, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
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.
Very few patients with inactive disease had low vitamin D levels, so most patients screened were ineligible. This made recruitment very slow, and the project was terminated.Suggests low vitamin D could be a marker of activity, rather than a cause
Peter D. Higgins, MD, PhD, MSc
University of Michigan
Shail M Govani, M.D., M.Sc.
University of Michigan
Hans Herfarth, MD, PhD
University of North Carolina
11 participants (actual enrollment reported by the registry).
First Submitted
August 1, 2014
First Posted
August 5, 2014
Study Start
April 2015
Date type not reportedThis date has not been verified as actual or estimated.
Treatment Study of Vitamin D Deficiency in Adolescents
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Primary Completion
April 2016
Actual (reported)Study Completion
April 2016
Actual (reported)Last Updated
October 6, 2017
Results First Posted
October 6, 2017
Record last verified: 2017-08
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Source: ClinicalTrials.gov.
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