The Vitamin D in Pediatric Crohn’s Disease is multicentric Randomized Controlled Trial of High Dose Vitamin D in Children With Newly Diagnosed Crohn’s Disease for the Prevention of Relapses.
Background: Many data suggest that pediatric Crohn’s disease is an important public health challenge: (a)The incidence and prevalence of pediatric-onset Crohn’s disease in Canada are among the highest in the world (13.9 per 100,000 children) as compared to elsewhere (2-5 per 100,000); (b) this burden appears to be on the rise; (c) the severity of illness at presentation of pediatric cases of Crohn’s disease is greater than it is in adults; (d) disease management is a challenge in view of the increased risk of relapses, surgery and complications; (e) the lifelong burden of Crohn’s disease, an incurable disease, is associated with morbidity, impaired quality of life, disability and long term risk of cancer in adulthood. Recent studies have described how varying doses of vitamin D can alter serum levels of 25 hydroxy-vitamin D, but no study has specifically addressed the question as to whether vitamin D supplementation can alter the rate of relapse/complications and/or quality of life in children with Crohn’s disease.
Specific Objectives: A supplementation of high doses of oral Vitamin D, as an adjunct therapy, decreases the incidence rate of relapse (primary aim) and improve the quality of life in children with newly diagnosed Crohn’s disease (secondary aim).
Methods: The Vitamin D in Pediatric Crohn’s disease (ViDiPeC) is a Canadian multicenter randomized pragmatic double-blinded controlled trial. A total of 316 children, aged 4-17 years, in remission of Crohn’s disease (Pediatric Crohn’s disease Activity Index (PCDAI) < 10 and fecal calprotectin (Fcal) lower than 100 µg/g), will be recruited in 9 Canadian centers and randomly assigned to one of the two following study arms:
(1) Experimental (high dose oral vitamin D3): – patients ≥40 kg: 4000 IU/day as induction for 4 weeks then 2000 IU/day as maintenance for 48 weeks; -patients < 40 kg: 3000 IU/day as induction for 4 weeks then 2000 IU/day as maintenance for 48 weeks;
(2) Controls: (standard dose oral vitamin D3): 600 IU /day for 52 weeks. The administration of vitamin D will be considered as an adjunct to conventional therapy.
The Primary outcome measure will be the occurrence of a Crohn’s disease relapse. A relapse is defined as the occurrence of at least one of the following: clinical symptoms (> 2 bowel movements per day, abdominal pain, fever > 38.5 x 3 days in a week, involuntary weight loss (> 1%), rectal bleeding, perianal disease or any of the following extra-intestinal symptoms (arthritis, uveitis, erythema nodosum, or pyoderma gangrenosum) AND a Fcal level > 100 µg/g AND a change in CD therapy.
Secondary outcomes measure will include: the quality of life at 26 weeks and 52 weeks, as measured by the IMPACT III questionnaire, the lapse of time from randomization to the first relapse, the number of relapses per patient per year, and the number of hospitalizations by 52 weeks. Safety assessment will be performed including risk for hypercalcemia, hypervitaminosis D and nephrocalcinosis.
Expected results: This trial is designed as a pragmatic RCT aiming to study the effectiveness of Vitamin D as a complementary therapy in newly diagnosed pediatric Crohn’s disease patients. This inexpensive therapy will help us improve the outcome of pediatric Crohn’s disease and give those children a better quality of life. Thus, our study will form the basis of clinical recommendations regarding the use of vitamin D as an adjunct therapy in children with Crohn’s disease.
This study has been approved by Health Canada and is supported by the Canadian Children Inflammatory Bowel Disease Network (CiDSCANN)