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Randomized Controlled Trial of High Dose Vitamin D in Children With Newly Diagnosed Crohn's Disease for the Prevention of Relapses (ViDiPeC)
The purpose of this study is to determine if vitamin D as an adjuvant therapy can improve the outcome (i.e. fewer relapses) and the quality of life, including levels of physical activity, in children with newly diagnosed Crohn's disease (CD).
Details
| Lead sponsor | St. Justine's Hospital |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 25 |
| Start date | 2016-02 |
| Completion | 2019-12-20 |
Conditions
- Crohn's Disease
Interventions
- Vitamin D3: 3000 or 4000 UI/day then 2,000 UI/day
- Vitamin D3 800 UI/day then 800 UI/day
Primary outcomes
- Occurrence of at least one relapse within 52 weeks after randomization in the trial. — within 52 weeks after inclusion in the study
A relapse is defined as the occurrence of clinical symptoms (\> 2 bowel movements per day, abdominal pain, fever, weight loss, perianal disease or extra-intestinal symptoms) and a pediatric Crohn's disease Activity Index (PCDAI) \> 30. The PCDAI is a validated and reproducible tool that was developed by consensus at a meeting of pediatric (Inflammatory bowel disease) IBD experts and subsequently validated in 12 North American institutions. It includes 11 domains, with clinical symptoms, physical examination, laboratory parameters, and growth. The PCDAI score can range from 0-100, with higher scores signifying more active disease. A score \< 10 is consistent with inactive disease; 11-30 indicates mild disease; \> 30 suggests moderate to severe disease. The PCDAI has been used in many pediatric trials.
Countries
Canada