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Terminated
NCT03999580
The Vitamin D in Pediatric Crohn's Disease ( ViDiPeC-2 )
Conditions: Crohn Disease
Sex: All
Ages: 4 Years – 18 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 55
Sponsor: Jantchou Prevost
Location: Stollery Children's Hospital Edmonton Alberta
Summary
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 diagnosed Crohn's disease (CD).
Eligibility Criteria
Inclusion Criteria:
1. Age at randomization between 4 and 17 years inclusively
2. Pediatric Crohn's Disease Activity Index (PCDAI) ≤ 10 with no clinical symptoms (abdominal pain or blood in the stool) at inclusion
3. Receiving a stable dose for at least 4 weeks of any of the following drugs: Thiopurines, Methotrexate, or TNF-α inhibitors (Infliximab/Adalimumab)
4. Dosage of fecal calprotectin lower than 250 µg/g stool at inclusion.
Exclusion Criteria:
1. History of surgery resulting in a permanent colostomy or ileostomy (because of the inability to calculate PCDAI at baseline)
2. Patients who have already been included in the pilots vitamin D trials
3. Patients actively enrolled in other CD drug trials.
Source: ClinicalTrials.gov (NCT03999580). StuddyBuddy aggregates publicly available trial information.