Crohn's Disease And Vitamin D
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.
| 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 :
- 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.
- 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.
- 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 :
- 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.
- 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
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
| 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 | |
University of Michigan
Crohn's and Colitis Foundation
| 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 |
| Responsible Party: | Peter Higgins, Assistant Professor, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT02208310 |
| 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:
| Crohn Disease Vitamin D Deficiency Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Avitaminosis Deficiency Diseases Malnutrition | Nutrition Disorders Vitamin D Ergocalciferols Cholecalciferol Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |
Source: https://clinicaltrials.gov/ct2/show/NCT02208310
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