Vitamin D Supplementation in Adult Crohn's Disease
VITD-CD
Vitamin D and Immunomodulation: Effects in Crohn's Disease
1 other identifier
interventional
117
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2012
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2011
CompletedFirst Posted
Study publicly available on registry
June 9, 2011
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedAugust 18, 2015
June 1, 2011
2.7 years
June 7, 2011
August 15, 2015
Conditions
Outcome Measures
Primary Outcomes (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.
12 Months
Study Arms (2)
vitamin D
ACTIVE COMPARATORCapsule, one taken daily
Placebo
PLACEBO COMPARATORCapsule, one taken daily
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital,
Dublin, Ireland
Related Publications (1)
O'Sullivan F, Raftery T, van Weele M, van Geffen J, McNamara D, O'Morain C, Mahmud N, Kelly D, Healy M, O'Sullivan M, Zgaga L. Sunshine is an Important Determinant of Vitamin D Status Even Among High-dose Supplement Users: Secondary Analysis of a Randomized Controlled Trial in Crohn's Disease Patients. Photochem Photobiol. 2019 Jul;95(4):1060-1067. doi: 10.1111/php.13086. Epub 2019 Mar 12.
PMID: 30649836DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria O'Sullivan, PhD
TCD
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research dietitian
Study Record Dates
First Submitted
June 7, 2011
First Posted
June 9, 2011
Study Start
April 1, 2012
Primary Completion
December 1, 2014
Study Completion
May 1, 2015
Last Updated
August 18, 2015
Record last verified: 2011-06