Crohn's Disease
Conditions
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.
Interventions
DIETARY_SUPPLEMENTVitamin D3
OTHERPlacebo
Sponsors
Queen Mary University of London
University of Dublin, Trinity College
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Ireland
Outcome results
None listed