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

This study is currently recruiting participants.
Verified June 2011 by University of Dublin, Trinity College
Sponsor:
Collaborator:
Queen Mary University of London
Information provided by (Responsible Party):
Tara Raftery, University of Dublin, Trinity College
ClinicalTrials.gov Identifier:
NCT01369667
First received: June 7, 2011
Last updated: January 14, 2013
Last verified: June 2011
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D and Immunomodulation: Effects in Crohn's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 130
Study Start Date: April 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2013 (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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients must fulfill the clinical criteria for diagnosis of Crohn's disease.
  • Subjects must have inactive CD for at least four weeks prior to study enrolment.
  • CRP <5 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369667

Contacts
Contact: Tara Raftery, BSc Hum Nut rafteryt@tcd.ie

Locations
Ireland
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital, Recruiting
Dublin 24, Ireland
Contact: Tara Raftery, BSc. Hum. Nut.         rafteryt@tcd.ie    
Sponsors and Collaborators
University of Dublin, Trinity College
Queen Mary University of London
Investigators
Principal Investigator: Maria O'Sullivan, PhD TCD
  More Information

No publications provided

Responsible Party: Tara Raftery, Research dietitian, University of Dublin, Trinity College
ClinicalTrials.gov Identifier: NCT01369667     History of Changes
Other Study ID Numbers: VITD/CD/01
Study First Received: June 7, 2011
Last Updated: January 14, 2013
Health Authority: Ireland: Research Ethics Committee

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Cholecalciferol
Vitamin D
 Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 21, 2013