We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01369667
First Posted: June 9, 2011
Last Update Posted: August 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Queen Mary University of London
Information provided by (Responsible Party):
Tara Raftery, University of Dublin, Trinity College
  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
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: June 7, 2011
First Posted: June 9, 2011
Last Update Posted: August 18, 2015
Last Verified: June 2011

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
Bone Density Conservation Agents