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

Status:	Terminated
Conditions:	Other Indications, Gastrointestinal, Crohns Disease
Therapuetic Areas:	Gastroenterology, Other
Healthy:	No
Age Range:	18 - 75
Updated:	10/8/2017
Start Date:	April 2015
End Date:	April 2016

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

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.

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.

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

We found this trial at

sites

Indiana University

425 University Blvd.
Indianapolis, Indiana 46202

(317) 274-4591