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

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ClinicalTrials.gov Identifier: NCT02208310
Recruitment Status : Terminated (Unable to enroll at rate anticipated, insufft low vitamin D in clin rem @ 5 sites)
First Posted : August 5, 2014
Results First Posted : October 6, 2017
Last Update Posted : October 6, 2017
Sponsor:
Collaborator:
Crohn's and Colitis Foundation
Information provided by (Responsible Party):
Peter Higgins, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Vitamin D Deficiency Drug: Cholecalciferol 10,000 IU Drug: Cholecalciferol 400 IU Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of High-Dose Vitamin D in Crohn's Disease
Study Start Date : April 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: Cholecalciferol 400 IU
Cholecalciferol 400 IU po daily
Other Name: Low dose vitamin D

Experimental: 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.
Drug: Cholecalciferol 10,000 IU
Cholecalciferol 10,000 IU po daily
Other Name: High Dose Vitamin D




Primary Outcome Measures :
  1. Composite Endpoint: Number of Participants With (Any of) a CD-related Hospitalization, CD-related Surgery, CD-related ER Visits and Steroid Prescriptions [ Time Frame: Day 180 ]

    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.


  2. Hypercalcemia [ Time Frame: Day 180 ]
    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.

  3. Incidence of Nephrolithiasis [ Time Frame: Day 180 ]
    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 :
  1. Crohn's Related Hospitalizations [ Time Frame: Day 180 ]
    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.

  2. Steroid Prescription Given (Dichotomous 0/1) [ Time Frame: Day 180 ]
    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

  3. Crohn's Related Surgeries (Dichotomous 0/1 Per Subject) [ Time Frame: Day 180 ]
    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

  4. Change in Modified Harvey-Bradshaw Index (HBI Without Examination) [ Time Frame: Day 180 ]

    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.


  5. Change in C-reactive Protein [ Time Frame: Day 180 ]
    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.

  6. Changes in Fecal Calprotectin [ Time Frame: 1 year ]
    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.

  7. Percent With Escalation of Therapy [ Time Frame: Day 180 ]
    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.

  8. Quality of Life Measure Changes [ Time Frame: Day 180 ]

    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.


  9. Change in Fatigue Measurements [ Time Frame: Day 180 ]

    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.


  10. Participants With at Least One Crohn's Related Emergency Department (ED) Visit [ Time Frame: Day 180 ]
    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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02208310


Locations
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United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46001
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 55240
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of Michigan
Crohn's and Colitis Foundation
Investigators
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Principal Investigator: Peter D. Higgins, MD, PhD, MSc University of Michigan
Study Director: Shail M Govani, M.D., M.Sc. University of Michigan
Study Director: Hans Herfarth, MD, PhD University of North Carolina

Publications:
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Responsible Party: Peter Higgins, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02208310     History of Changes
Other Study ID Numbers: CCFA-329225
First Posted: August 5, 2014    Key Record Dates
Results First Posted: October 6, 2017
Last Update Posted: October 6, 2017
Last Verified: August 2017

Keywords provided by Peter Higgins, University of Michigan:
Crohn's disease
Vitamin D deficiency

Additional relevant MeSH terms:
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Vitamins
Vitamin D
Crohn Disease
Vitamin D Deficiency
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents