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

NCT02208310 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2017-10-06

Study results available
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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.

Conditions

Interventions

DRUG

Cholecalciferol 10,000 IU

Cholecalciferol 10,000 IU po daily

DRUG

Cholecalciferol 400 IU

Cholecalciferol 400 IU po daily

Sponsors & Collaborators

Principal Investigators

  • Peter D. Higgins, MD, PhD, MSc · University of Michigan

  • Shail M Govani, M.D., M.Sc. · University of Michigan

  • Hans Herfarth, MD, PhD · University of North Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02208310 on ClinicalTrials.gov