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

This study has been completed.
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: August 15, 2015
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 ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 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 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
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

Locations
Ireland
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
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: August 15, 2015
Health Authority: Ireland: Research Ethics Committee

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

ClinicalTrials.gov processed this record on August 31, 2015