NCT02208310

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn's Disease
• Vitamin D Deficiency

Interventions

Type	Name	Description
DRUG	Cholecalciferol 10,000 IU	Cholecalciferol 10,000 IU po daily
DRUG	Cholecalciferol 400 IU	Cholecalciferol 400 IU po daily

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2014-08-05
• Last updated: 2017-10-06
• Results posted: 2017-10-06

Locations

4 sites across 1 country: United States