Vitamin D Supplementation in Adult Crohn's Disease (VITD-CD)

August 15, 2015 updated by: Tara Raftery, University of Dublin, Trinity College

Vitamin D and Immunomodulation: Effects in Crohn's Disease

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin 24, Ireland
        • Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: vitamin D
Capsule, one taken daily
Dietary supplement: Vitamin D3
PLACEBO_COMPARATOR: Placebo
Capsule, one taken daily
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dublin, Trinity College

Collaborators

Queen Mary University of London

Investigators

  • Principal Investigator: Maria O'Sullivan, PhD, TCD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

June 7, 2011

First Submitted That Met QC Criteria

June 7, 2011

First Posted (ESTIMATE)

June 9, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 18, 2015

Last Update Submitted That Met QC Criteria

August 15, 2015

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VITD/CD/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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