Vitamin D Supplementation in Adult Crohn's Disease

Crohn's Disease Clinical Trial

— VITD-CD  

Official title:

Vitamin D and Immunomodulation: Effects in Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01369667
• Other study ID #: VITD/CD/01
• Status: Completed
• Phase: Phase 4
• First received: June 7, 2011
• Last updated: August 15, 2015
• Start date: April 2012
• Est. completion date: May 2015

Study information

• Verified date: June 2011
• Source: University of Dublin, Trinity College
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether vitamin D supplementation is effective in the prevention of relapse in Crohn's disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: May 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• All patients must fulfill the clinical criteria for diagnosis of Crohn's disease.

• Subjects must have inactive CD as defined by CDAI < 150

• CRP </=10 mg/L.

Exclusion Criteria:

• Pregnant and lactating women.

• Known hypersensitivity to vitamin D.

• Hypercalcaemia

• Current supplemental intake of vitamin D3 >800 IU/D.

• Diagnosis of any of the following: active tuberculosis, sarcoidosis, hyperparathyroidism, pseudohyperparathyroidism, renal failure or malignancy, active TB, sarcoidosis, lymphoma.

• Participation in a concurrent clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Dietary Supplement:
• Vitamin D3

Other:
• Placebo

Locations

Country	Name	City	State
Ireland	Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital,	Dublin 24

Sponsors (2)

Lead Sponsor	Collaborator
University of Dublin, Trinity College	Queen Mary University of London

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Relapse: defined as a CDAI of 150 or more and an increase in CDAI of more than 70 compared with baseline during the 12 month follow-up period.		12 Months	Yes