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

Phase 4

Terminated

• Conditions: Crohn's Disease; Vitamin D Deficiency
• Interventions: Drug: Cholecalciferol 400 IU; Drug: Cholecalciferol 10,000 IU

• Registration Number: NCT02208310
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2014-08-01
• Study First Submitted QC: 2014-08-01
• Study First Posted: 2014-08-05
• Study Start: 2015-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Results First Submitted: 2017-03-19
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-31
• Last Update Submitted: 2017-08-31
• Results First Posted: 2017-10-06
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Diagnosis of CD
• Age >= 18 and <75
• Vitamin D deficiency or insufficiency (serum 25-hydroxyvitamin D < 30ng/ml)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low Dose Vitamin D	Cholecalciferol 400 IU	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.
High Dose Vitamin D	Cholecalciferol 10,000 IU	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.

Primary Outcome Measures

Name	Time	Method
Composite Endpoint: Number of Participants With (Any of) a CD-related Hospitalization, CD-related Surgery, CD-related ER Visits and Steroid Prescriptions	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.
Hypercalcemia	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.
Incidence of Nephrolithiasis	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

Name	Time	Method
Crohn's Related Hospitalizations	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.
Steroid Prescription Given (Dichotomous 0/1)	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
Crohn's Related Surgeries (Dichotomous 0/1 Per Subject)	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
Change in Modified Harvey-Bradshaw Index (HBI Without Examination)	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.
Change in C-reactive Protein	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.
Changes in Fecal Calprotectin	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.
Percent With Escalation of Therapy	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.
Quality of Life Measure Changes	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.
Change in Fatigue Measurements	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.
Participants With at Least One Crohn's Related Emergency Department (ED) Visit	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

Trial Locations

Locations (4)

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