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

• Status: Terminated
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Collaborator: Crohn's and Colitis Foundation
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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