Trial of High Dose Vitamin D in Patient's With Crohn's Disease

Crohn's Disease Clinical Trial

— RODIN-CD  

Official title:

A Randomized Controlled Trial of High-Dose Vitamin D in Crohn's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02208310
• Other study ID #: CCFA-329225
• Status: Terminated
• Phase: Phase 4
• First received: August 1, 2014
• Last updated: August 31, 2017
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: August 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Subjects are randomized to low or high dose vitamin D, and outcomes including steroid prescriptions, CD-related hospitalizations, CD-related surgeries, and the modified Harvey-Bradshaw Index are measured.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of CD

• Age >= 18 and <75

• Vitamin D deficiency or insufficiency (serum 25-hydroxyvitamin D < 30ng/ml)

Exclusion Criteria:

• Corticosteroid use in the last 4 weeks

• 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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Vitamin D Deficiency

Intervention

Drug:
• Cholecalciferol 10,000 IU
Cholecalciferol 10,000 IU po daily
• Cholecalciferol 400 IU
Cholecalciferol 400 IU po daily

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Indiana University	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Crohn's and Colitis Foundation

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

Jørgensen 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	Crohn's Related Hospitalizations	Dichotomous (0/1) endpoint for each subject, depending on whether a CD-related hospitalization occurred. Relatedness to Crohn's disease as judged by the DSMB. 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
Secondary	Steroid Prescription Given (Dichotomous 0/1)	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. No steroid prescriptions occurred	Day 180
Secondary	Crohn's Related Surgeries (Dichotomous 0/1 Per Subject)	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. No CD-related surgeries occurred in the 1 subject	Day 180
Secondary	Change in Modified Harvey-Bradshaw Index (HBI Without Examination)	modified Harvey-Bradshaw is a disease assessment scale. 0 is the lowest score and would be considered remission. Scale ranges to over 16 (upper limit is defined by the number of bowel movements in the prior day) with numbers over 16 being severe disease. A positive change (such as that indicated below) therefore references slightly worsening disease while a negative change references improving disease.; 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. 1 subject had an increase of 1 unit on the modified HBI.	Day 180
Secondary	Change in C-reactive Protein	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. The delta between first (baseline) and last CRP (Day 180) is reported here.	Day 180
Secondary	Changes in Fecal Calprotectin	Originally planned to collect at Day 180 and Day 360. Results were not collected on any subjects, as the one participant did not provide a stool sample.	1 year
Secondary	Percent With Escalation of Therapy	Patients who had to have a change in therapy 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
Secondary	Quality of Life Measure Changes	change in quality of life measures based on Inflammatory bowel disease questionnaire (IBD-Q).; Scale from 0 to 224 with 0 being the poorest quality of life and 224 being the highest quality of life. A positive change indicates improvement while a negative change indicates worsening.; 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
Secondary	Change in Fatigue Measurements	Change in FACIT-F scale over the year. Scale is 0-160 with 0 being no fatigue and 160 being extreme fatigue. A positive change indicates worsening in symptoms and a negative change indicates an improvement.; 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
Secondary	Participants With at Least One Crohn's Related Emergency Department (ED) Visit	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. No CD-related ED visits occurred in the 1 subject	Day 180