The Vitamin D in Pediatric Crohn's Disease (ViDiPeC)
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|ClinicalTrials.gov Identifier: NCT02186275|
Recruitment Status : Completed
First Posted : July 10, 2014
Last Update Posted : September 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: Vitamin D3: 3000 or 4000 UI/day then 2,000 UI/day Drug: Vitamin D3 800 UI/day then 800 UI/day||Phase 3|
Crohn's disease is a chronic inflammatory condition affecting all segments of the digestive tract from the mouth to the anus. This condition is associated with an increased risk of relapses throughout the course of the disease. Nearly 25% of patients with Crohn's disease are in the pediatric age range. Many epidemiological data are in favor of an increase incidence of pediatric Crohn's disease. Environmental factors could explain this increased incidence. Among them sunlight exposure and vitamin D deficiency have been suggested by many authors.
Recent studies have described how varying doses of oral vitamin D supplementation can alter serum levels of 25 hydroxyvitamin D (25(OH)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 diagnosed with CD.
Current treatments of CD at diagnosis are effective around the time of diagnosis, but in the short and long term, some of these therapies are inefficient or lead to allergic or intolerance reactions. Altogether the rate of relapses in the year after diagnosis is significant. Thus, different therapeutic approaches must be investigated with the aim of lowering the burden of the disease.
From November 2012 to July 2013, we conducted an open label pilot cohort study aiming to investigate the bioavailability and tolerance of high doses of vitamin D3 (3,000 IU or 4,000 IU per day) administered orally as an adjunct therapy in 20 children with newly diagnosed pediatric CD (http://clinicaltrials.gov/ct2/show/NCT01692808). Data from laboratory studies, observational research and pilot trials taken together suggest that vitamin D can be of great importance in the genesis and progression of CD. Vitamin D deficiency could be a true risk factor for disease occurrence and/or relapses. The results of our pilot study demonstrate that in children with active CD at diagnosis, a daily dose of 4,000 IU of vitamin D is well tolerated and quickly increases the blood levels of 25OHD3 to 100 nmol/L or above in 100% of children with CD at diagnosis. Moreover a maintenance dosage of 2,000 IU a day is required (and sufficient) for maintaining this target over several months. Currently there is no adequately powered study in the pediatric CD population exploring the relationship between vitamin D therapy at diagnosis and CD outcomes.
We propose a randomized controlled trial (RCT) to study the efficacy of high-dose oral vitamin D, as adjunct therapy, in children with newly diagnosed CD, to reduce the relapse rate and to improve patients' quality of life.
Primary Efficacy End Point: The proportion of patient with at least one relapse 52 weeks after randomization.
Secondary efficacy endpoint: Quality of life scores, Cumulative steroid dose, Time to first relapse, Duration of corticotherapy, Number of relapses, Number of hospitalizations Safety Endpoint : incidence of hypercalcemia (defined as a corrected serum calcium level >2.65 mmol/L), incidence of hypercalciuria (defined as urinary calcium to creatinine molar ratio ≥1.50), incidence of supra-optimal levels of 25OHD3 as defined by a serum level ≥ 250 nmol/L, rate of study discontinuation due to hypercalcemia or hypercalciuria.
Efficacy Variable: Occurrence of relapse, Time to relapse, Change in QoL score from baseline to 26 weeks, 52 weeks. Change in physical activity score from baseline to 26 weeks, 52 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Randomized Controlled Trial of High Dose Vitamin D in Children With Newly Diagnosed Crohn's Disease for the Prevention of Relapses|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||December 20, 2019|
|Actual Study Completion Date :||December 20, 2019|
Experimental: Vitamin D3 3000 or 4000 UI/day then 2,000 UI/day
3000 UI or 4,000 UI/day as induction therapy (according to weight) for 4 weeks then 2,000 UIday as maintenance therapy for 48 weeks.
The administration of vitamin D will be considered as an adjunct to conventional therapy (corticosteroids, exclusive enteral nutrition or immunosuppressive agents (ISA)).
Drug: Vitamin D3: 3000 or 4000 UI/day then 2,000 UI/day
Other Name: Cholecalciferol
Active Comparator: Vitamin D3 800 UI/day then 800 UI/day
800 UI/day as induction therapy for 4 weeks, then 800 UI/day as maintenance therapy for 48 weeks. The administration of vitamin D will be considered as an adjunct to conventional therapy (corticosteroids, exclusive enteral nutrition or immunosuppressive agents (ISA)).
Drug: Vitamin D3 800 UI/day then 800 UI/day
Other Name: Cholecalciferol
- Occurrence of at least one relapse within 52 weeks after randomization in the trial. [ Time Frame: within 52 weeks after inclusion in the study ]
A relapse is defined as the occurrence of clinical symptoms (> 2 bowel movements per day, abdominal pain, fever, weight loss, perianal disease or extra-intestinal symptoms) and a pediatric Crohn's disease Activity Index (PCDAI) > 30.
The PCDAI is a validated and reproducible tool that was developed by consensus at a meeting of pediatric (Inflammatory bowel disease) IBD experts and subsequently validated in 12 North American institutions. It includes 11 domains, with clinical symptoms, physical examination, laboratory parameters, and growth.
The PCDAI score can range from 0-100, with higher scores signifying more active disease. A score < 10 is consistent with inactive disease; 11-30 indicates mild disease; > 30 suggests moderate to severe disease. The PCDAI has been used in many pediatric trials.
- the lapse of time from randomization to first relapse [ Time Frame: from randomization to first relapse ]
- the number of relapses per patient per year [ Time Frame: within 52 weeks after randomization in the trial ]
- 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 quality of life [ Time Frame: at 26 weeks and 52 weeks ]as measured by the IMPACT III questionnaire. IMPACT III is a validated questionnaire that assesses disease-related quality-of-life in multiple domains of care in pediatric IBD (bowel symptoms; systemic symptoms; emotional functioning; functional/social impairment; body image; test-treatments). Overall scores for IMPACT III range from 35 to 175 with higher scores associated with better quality of life
- Change in the level of physical activities [ Time Frame: between randomization and 52 weeks later ]As measured by the Canadian Health Measures Survey (CHMS) - Children's Physical ActivityQuestionnaire
- Changes in bone mineral density [ Time Frame: between randomization and 52 weeks later ]As assessed by dual energy X-ray absorptiometry (DXA)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186275
|Edmonton Clinic Health Academy|
|Edmonton, Alberta, Canada, T6G 1C9|
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada, V6H 3V4|
|Health Science Center Pediatric|
|Winnipeg, Manitoba, Canada, R3A 1R9|
|Canada, Newfoundland and Labrador|
|Janeway Children's Health Centre|
|St. John's, Newfoundland and Labrador, Canada, A1B 3V6|
|Canada, Nova Scotia|
|IWK Health Centre|
|Halifax, Nova Scotia, Canada, B3K 6R8|
|Hamilton, Ontario, Canada, L8S4L8|
|Hospital for Sick Childrens|
|Toronto, Ontario, Canada, M5G 1X8|
|Montreal, Quebec, Canada, H3T1C5|
|Montreal Children's Hospital (Montreal).|
|Montréal, Quebec, Canada, H3H 1P3|
|Centre Hospitalier Universitaire Laval|
|Québec, Canada, G1V 4G2|
|Principal Investigator:||Prevost Jantchou, MD||St. Justine's Hospital|