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.
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.
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
4
sites
Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Hans H. Herfarth, MD PhD
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
Click here to add this to my saved trials
425 University Blvd.
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Monika Fischer, MD
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
Click here to add this to my saved trials
101 Jessup Hall
Iowa City, Iowa 52242
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Steven Polyak, MD
University of Iowa With just over 30,000 students, the University of Iowa is one of...
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Shail M Govani, MD, MSc
University of Michigan The University of Michigan was founded in 1817 as one of the...
Click here to add this to my saved trials