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

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ClinicalTrials.gov Identifier: NCT01369667
Recruitment Status : Completed
First Posted : June 9, 2011
Last Update Posted : August 18, 2015
Sponsor:
Collaborator:
Queen Mary University of London
Information provided by (Responsible Party):
Tara Raftery, University of Dublin, Trinity College

Brief Summary:
The purpose of this study is to determine whether vitamin D supplementation is effective in the prevention of relapse in Crohn's disease.

Condition or disease Intervention/treatment Phase
Crohn's Disease Dietary Supplement: Vitamin D3 Other: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
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
Study Start Date : April 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: vitamin D
Capsule, one taken daily
Dietary Supplement: Vitamin D3
Placebo Comparator: Placebo
Capsule, one taken daily
Other: Placebo



Primary Outcome Measures :
  1. 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 ]


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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.

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

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 Posted: June 9, 2011    Key Record Dates
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