The Vitamin D in Pediatric Crohn's Disease ( ViDiPeC-2 )

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jantchou Prevost
• Treatments: Cholecalciferol; Ergocalciferols; Immunosuppressive Agents; Vitamin D; Vitamins

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.