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Trial of High Dose Vitamin D in Patient's With Crohn's Disease (RODIN-CD)

Primary Purpose

Crohn's Disease, Vitamin D Deficiency

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cholecalciferol 10,000 IU
Cholecalciferol 400 IU
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease, Vitamin D deficiency

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana University
  • University of Iowa
  • University of Michigan
  • University of North Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Low Dose Vitamin D

High Dose Vitamin D

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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
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
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.
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.
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.
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.
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.
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.
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

Full Information

First Posted
August 1, 2014
Last Updated
August 31, 2017
Sponsor
University of Michigan
Collaborators
Crohn's and Colitis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02208310
Brief Title
Trial of High Dose Vitamin D in Patient's With Crohn's Disease
Acronym
RODIN-CD
Official Title
A Randomized Controlled Trial of High-Dose Vitamin D in Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Unable to enroll at rate anticipated, insufft low vitamin D in clin rem @ 5 sites
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Crohn's and Colitis Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Vitamin D Deficiency
Keywords
Crohn's disease, Vitamin D deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose Vitamin D
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High Dose Vitamin D
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol 10,000 IU
Other Intervention Name(s)
High Dose Vitamin D
Intervention Description
Cholecalciferol 10,000 IU po daily
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol 400 IU
Other Intervention Name(s)
Low dose vitamin D
Intervention Description
Cholecalciferol 400 IU po daily
Primary Outcome Measure Information:
Title
Composite Endpoint: Number of Participants With (Any of) a CD-related Hospitalization, CD-related Surgery, CD-related ER Visits and Steroid Prescriptions
Description
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.
Time Frame
Day 180
Title
Hypercalcemia
Description
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.
Time Frame
Day 180
Title
Incidence of Nephrolithiasis
Description
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.
Time Frame
Day 180
Secondary Outcome Measure Information:
Title
Crohn's Related Hospitalizations
Description
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.
Time Frame
Day 180
Title
Steroid Prescription Given (Dichotomous 0/1)
Description
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
Time Frame
Day 180
Title
Crohn's Related Surgeries (Dichotomous 0/1 Per Subject)
Description
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
Time Frame
Day 180
Title
Change in Modified Harvey-Bradshaw Index (HBI Without Examination)
Description
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.
Time Frame
Day 180
Title
Change in C-reactive Protein
Description
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.
Time Frame
Day 180
Title
Changes in Fecal Calprotectin
Description
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.
Time Frame
1 year
Title
Percent With Escalation of Therapy
Description
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.
Time Frame
Day 180
Title
Quality of Life Measure Changes
Description
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.
Time Frame
Day 180
Title
Change in Fatigue Measurements
Description
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.
Time Frame
Day 180
Title
Participants With at Least One Crohn's Related Emergency Department (ED) Visit
Description
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
Time Frame
Day 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter D. Higgins, MD, PhD, MSc
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shail M Govani, M.D., M.Sc.
Organizational Affiliation
University of Michigan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hans Herfarth, MD, PhD
Organizational Affiliation
University of North Carolina
Official's Role
Study Director
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46001
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
55240
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20491740
Citation
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.
Results Reference
background
PubMed Identifier
22241842
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.
Results Reference
background
PubMed Identifier
11053501
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. doi: 10.1093/jn/130.11.2648.
Results Reference
background
PubMed Identifier
22155183
Citation
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.
Results Reference
background

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

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