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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02010762 |
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Date of registration:
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10/12/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease
DETECT |
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Scientific title:
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The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease: a Placebo-controlled Randomized Trial |
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Date of first enrolment:
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February 2013 |
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Target sample size:
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142 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02010762 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Geert D'Haens, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age = 18 years, either male or female
- Established CD
- First or second ileocolonic resection with ileocolonic anastomosis and removal of all
tissue macroscopically affected by CD according to the surgeon
- Able to give written informed consent
- Normal levels of serum calcium at inclusion
- Being able to resume oral intake within 2 weeks after surgery
Exclusion Criteria:
- Patients in whom not all visible CD has been resected
- Active fistulizing perianal disease (requiring anti TNF treatment)
- Extensive small bowel resection
- Third, fourth or later ileocolonic resection
- Patients undergoing ileocoecal resection in the Lir!c Trial (NTR 1150,
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1150)
- A history of primary hyperparathyroidism
- A history of osteoporosis for which calcium and Vitamin D treatment are mandatory
- A history of another granulomatous diseases (sarcoidosis, tuberculosis)
- Pregnant or breastfeeding (at index date) female patients
- Patients undergoing other resections than ileocolonic resections
- Patients who prefer to use open-label vitamin D preparations
- Patients who will continue to use tanning beds
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Drug: Vitamin D
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Drug: Placebo
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Primary Outcome(s)
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Proportion of patients with clinically significant endoscopic recurrence at 6 months of vitamin D3 treatment postoperatively, defined as endoscopic Rutgeerts' score =i2.
[Time Frame: 0-6 months]
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Secondary Outcome(s)
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2. NOD2 gene mutations: the difference in response to vitamin D treatment in patients NOD2+ versus patients NOD2-.
[Time Frame: 0-6 months]
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3. Difference in significant recurrence among all patients with low vitamin D at baseline
[Time Frame: 0-6 months]
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1. Clinical CD recurrence measured with CDAI among the 2 groups at week 26 (CDAI =220)
[Time Frame: 0-6 months]
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5. Any adverse events
[Time Frame: 0-6 months]
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4. Quality of life, measured by one validated questionnaire for IBD patients (IBD-Q) and two general questionnaires (SF-36 and EuroQol)
[Time Frame: 0-6 months]
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Secondary ID(s)
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NL.45391.018.13
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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