The Vitamin D in Pediatric Crohn's Disease (NCT02186275) | Clinical Trial Compass
CompletedPhase 3
The Vitamin D in Pediatric Crohn's Disease
Canada25 participantsStarted 2016-02
Plain-language 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).
Who can participate
Age range
9 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of at least one relapse within 52 weeks after randomization in the trial.
Timeframe: within 52 weeks after inclusion in the study