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

This study has been completed.
Queen Mary University of London
Information provided by (Responsible Party):
Tara Raftery, University of Dublin, Trinity College Identifier:
First received: June 7, 2011
Last updated: August 15, 2015
Last verified: June 2011
The purpose of this study is to determine whether vitamin D supplementation is effective in the prevention of relapse in Crohn's disease.

Condition Intervention Phase
Crohn's Disease Dietary Supplement: Vitamin D3 Other: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D and Immunomodulation: Effects in Crohn's Disease

Resource links provided by NLM:

Further study details as provided by Tara Raftery, University of Dublin, Trinity College:

Primary Outcome Measures:
  • 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 ]

Enrollment: 117
Study Start Date: April 2012
Study Completion Date: May 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: vitamin D
Capsule, one taken daily
Dietary Supplement: Vitamin D3
Placebo Comparator: Placebo
Capsule, one taken daily
Other: Placebo


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01369667

Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital,
Dublin 24, Ireland
Sponsors and Collaborators
University of Dublin, Trinity College
Queen Mary University of London
Principal Investigator: Maria O'Sullivan, PhD TCD
  More Information

Responsible Party: Tara Raftery, Research dietitian, University of Dublin, Trinity College Identifier: NCT01369667     History of Changes
Other Study ID Numbers: VITD/CD/01
Study First Received: June 7, 2011
Last Updated: August 15, 2015

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on August 18, 2017