The Vitamin D in Pediatric Crohn's Disease

• Status: Completed
• Trial end date: 2019-12-20
• 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 with newly diagnosed Crohn's disease (CD).

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

Details

• Lead Sponsor: St. Justine's Hospital
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Cholecalciferol; Ergocalciferols; Immunosuppressive Agents; Vitamin D; Vitamins

Criteria

Eligibility Criteria:

• Diagnosis of CD by the usual clinical, endoscopic and histological criteria and classified according to the Paris classification

Inclusion Criteria:

• Age at randomization between 9 and 18 years inclusively

• Interval between diagnosis and randomization between 2 weeks and 6 months after the diagnosis

• Pediatric Crohn's Disease Activity Index (PCDAI) ≤ 30 at inclusion

• Concurrent treatment with corticosteroids and/or enteral nutrition and/or thiopurines (azathioprine, 6-mercaptopurine) and/or methotrexate and/or 5-aminosalicylic acid (5-ASA) and/or TNF-α inhibitors (Infliximab, Adalimumab).

Exclusion Criteria:

• Patient diagnosed with severe complex perianal fistulizing CD (defined as the presence at diagnosis of a high intersphincteric, transsphincteric, extrasphincteric, or suprasphincteric complex perianal fistula)

• Known chronic liver cholestasis (defined by an elevation of conjugated bilirubin and/or gamma glutamyl transferase > 3 upper limit normal)

• Known renal dysfunction requiring chronic dialysis or creatinine ≥ 100 micromol/L.

• Known congenital bone disease

• Known cystic fibrosis or other exocrine pancreatic insufficiency.

• Currently treated with anticonvulsants metabolized through cytochrome P-450

• Unable to take oral capsule form.