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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by University of Dublin, Trinity College.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 22, 2014