The Vitamin D in Pediatric Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02186275
• Date of registration: 04/07/2014
• Prospective Registration: Yes
• Primary sponsor: St. Justine's Hospital
• Public title: The Vitamin D in Pediatric Crohn's Disease ViDiPeC
• Scientific title: Randomized Controlled Trial of High Dose Vitamin D in Children With Newly Diagnosed Crohn's Disease for the Prevention of Relapses
• Date of first enrolment: February 2016
• Target sample size: 25
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02186275
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Canada

Contacts

• Name: Prevost Jantchou, MD
• Affiliation: St. Justine's Hospital

Key inclusion & exclusion 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-a 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.



Age minimum: 9 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Vitamin D3: 3000 or 4000 UI/day then 2,000 UI/day

Drug: Vitamin D3 800 UI/day then 800 UI/day

Primary Outcome(s)

Occurrence of at least one relapse within 52 weeks after randomization in the trial. [Time Frame: within 52 weeks after inclusion in the study]

Secondary Outcome(s)

The quality of life [Time Frame: at 26 weeks and 52 weeks]

the duration of corticotherapy [Time Frame: between randomization and 52 weeks later]

The number of CD related hospitalizations [Time Frame: between randomization and 52 weeks later]

the number of relapses per patient per year [Time Frame: within 52 weeks after randomization in the trial]

the lapse of time from randomization to first relapse [Time Frame: from randomization to first relapse]

Secondary ID(s)

JP2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Canadian Institutes of Health Research (CIHR)