Crohn DiseasePhase 3ViDiPeC-2NCT03999580
The Vitamin D in Pediatric Crohn's Disease ( ViDiPeC-2 )
A Phase 3 study testing vitamin D3 in people with Crohn Disease, run by Jantchou Prevost at 7 sites in Canada.
Trial 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 diagnosed Crohn's disease (CD). Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 7 sitesCanada
- Study dates
- 7 Feb 2020to 29 Sep 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age at randomization between 4 and 17 years inclusively
- Pediatric Crohn's Disease Activity Index (PCDAI) ≤ 10 with no clinical symptoms (abdominal pain or blood in the stool) at inclusion
- Receiving a stable dose for at least 4 weeks of any of the following drugs: Thiopurines, Methotrexate, or TNF-α inhibitors (Infliximab/Adalimumab)
- Dosage of fecal calprotectin lower than 250 µg/g stool at inclusion.
Who cannot join
- History of surgery resulting in a permanent colostomy or ileostomy (because of the inability to calculate PCDAI at baseline)
- Patients who have already been included in the pilots vitamin D trials
- Patients actively enrolled in other CD drug trials.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Stollery Children's Hospital
Edmonton, Alberta, T6G 1C9
McMaster University
Hamilton, Ontario, L8N 3Z5
London Health Sciences Centre
London, Ontario, N6A 5W9
Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4
Children's Hospital
Winnipeg, Manitoba, R3A 1S1
About this study
Official title: A Pragmatic Randomized Controlled Trial on High Dose Vitamin D to Prevent Relapses of Crohn's Disease in Children
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 diagnosed Crohn's disease (CD).
Read the detailed description
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 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
- Conditions
- Crohn Disease
- Being tested
- vitamin D3
- Keywords
- Crohn, vitamin D, remission, inflammation, tolerance
- Medical subject headings
- Crohn Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D3Drug
Also called cholecalciferol
3000 or 4000 UI/ day:
Weight at inclusion < 40 kg : 1 ml per day of the selected concentration at induction and 1ml per day of the selected concentration at maintenance.
Weight at inclusion ≥ 40 kg : 1 ml per day of the selected concentration at induction and 1 ml per day of the selected concentration at maintenance
600 UI/ day:
Weight at inclusion < 40 kg :1 ml per day of the selected concentration (600 IU) at induction and 1 ml per day of the selected concentration (600 IU) at maintenance.
Weight at inclusion ≥ 40 kg : 1 ml per day of the selected concentration (600 IU) at induction and 1 ml per day of the selected concentration (600 IU) at maintenance
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm: | Experimental | 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 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). Receives: Drug: vitamin D3 |
| Control Arm: | Active comparator | Active Comparator: Vitamin D3 600 UI/day then 600 UI/day
600 UI/day as induction therapy for 4 weeks, then 600 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)). Receives: Drug: vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse
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) less than 10.
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.
Measured: Within 52 weeks after randomization in the study
Secondary outcomes (4)
Lapse of time from randomization to first relapse
numbers of days between the randomisation and the first relapse
Measured: From date of randomization until the date of first relapse, assessed up to 52 weeks after randomization in the study
Number of relapses per patient per year
numbers of relapses during the entire study
Measured: Within 52 weeks after randomization in the study
Number of hospitalizations per year
numbers of hospitalizations during the entire study
Measured: Between randomization and Week 52
Improvement of the Quality of life
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
Measured: At week 26 and week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start7 Feb 2020
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Why it stopped: Enrollment stopped at 55 of 316 planned participants due to recruitment challenges related to the COVID-19 pandemic and funding constraints. All enrolled participants completed 52-week follow-up.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Time zero for each patient will be the day of randomization. Patients will be randomly assigned (1:1 ratio) in one of two study arms: 3,000 or 4,000 IU/day, according to the patient body weight, as induction for 4 weeks then 2,000 IU/day as maintenance for 48 weeks. Control: 600 IU/day of Vitamin D as induction (4 weeks) and maintenance (48 weeks).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jantchou Prevost
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jantchou Prevost, St. Justine's Hospital
- Investigators
- Prevost Jantchou, MD,PhD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999580
- Sponsor's protocol ID
- MP-21-2019-2095
- Acronym
- ViDiPeC-2
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2019
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jantchou, P., Mailhot, G., Ezri, J., Le Deist, F., Deslandres, C., & Delvin, E. (2014). P-102: Bioavailability and tolerance of high doses vitamin D in children with newly diagnosed Crohn's disease. Journal of Crohn's and Colitis, 8, S432. doi:10.1016/s1873-9946(14)50130-4
Jantchou P, Clavel-Chapelon F, Racine A, Kvaskoff M, Carbonnel F, Boutron-Ruault MC. High residential sun exposure is associated with a low risk of incident Crohn's disease in the prospective E3N cohort. Inflamm Bowel Dis. 2014 Jan;20(1):75-81. doi: 10.1097/01.MIB.0000436275.12131.4f.
PubMed 24247650
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Controlled Trial on High Dose Vitamin D to Prevent Relapses of Crohn's Disease in Children
- ClinicalTrials.gov ID
- NCT03999580
- Acronym / sponsor ID
- ViDiPeC-2 / MP-21-2019-2095
- Conditions
- Crohn Disease
- Keywords
- Crohn, vitamin D, remission, inflammation, tolerance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment stopped at 55 of 316 planned participants due to recruitment challenges related to the COVID-19 pandemic and funding constraints. All enrolled participants completed 52-week follow-up.
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Jantchou PrevostUniversity, hospital or other
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 diagnosed Crohn's disease (CD).
Detailed description
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Time zero for each patient will be the day of randomization. Patients will be randomly assigned (1:1 ratio) in one of two study arms: 3,000 or 4,000 IU/day, according to the patient body weight, as induction for 4 weeks then 2,000 IU/day as maintenance for 48 weeks. Control: 600 IU/day of Vitamin D as induction (4 weeks) and maintenance (48 weeks).
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm: | Experimental | Drug: vitamin D3Experimental: 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 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). |
| Control Arm: | Active comparator | Drug: vitamin D3Active Comparator: Vitamin D3 600 UI/day then 600 UI/day 600 UI/day as induction therapy for 4 weeks, then 600 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)). |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age at randomization between 4 and 17 years inclusively
- Pediatric Crohn's Disease Activity Index (PCDAI) ≤ 10 with no clinical symptoms (abdominal pain or blood in the stool) at inclusion
- Receiving a stable dose for at least 4 weeks of any of the following drugs: Thiopurines, Methotrexate, or TNF-α inhibitors (Infliximab/Adalimumab)
- Dosage of fecal calprotectin lower than 250 µg/g stool at inclusion.
Key exclusion criteria (3 listed)
- History of surgery resulting in a permanent colostomy or ileostomy (because of the inability to calculate PCDAI at baseline)
- Patients who have already been included in the pilots vitamin D trials
- Patients actively enrolled in other CD drug trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin D3Also: cholecalciferol3000 or 4000 UI/ day: Weight at inclusion < 40 kg : 1 ml per day of the selected concentration at induction and 1ml per day of the selected concentration at maintenance. Weight at inclusion ≥ 40 kg : 1 ml per day of the selected concentration at induction and 1 ml per day of the selected concentration at maintenance 600 UI/ day: Weight at inclusion < 40 kg :1 ml per day of the selected concentration (600 IU) at induction and 1 ml per day of the selected concentration (600 IU) at maintenance. Weight at inclusion ≥ 40 kg : 1 ml per day of the selected concentration (600 IU) at induction and 1 ml per day of the selected concentration (600 IU) at maintenance | Drug | Control Arm:, Experimental Arm: |
Primary outcome
Relapse
Time frame: Within 52 weeks after randomization 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) less than 10. 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.
4 secondary outcomes
Lapse of time from randomization to first relapse
Time frame: From date of randomization until the date of first relapse, assessed up to 52 weeks after randomization in the study
Number of relapses per patient per year
Time frame: Within 52 weeks after randomization in the study
Number of hospitalizations per year
Time frame: Between randomization and Week 52
Improvement of the Quality of life
Time frame: At week 26 and week 52
Results and safety
The study was stopped early (reason given: Enrollment stopped at 55 of 316 planned participants due to recruitment challenges related to the COVID-19 pandemic and funding constraints. All enrolled participants completed 52-week follow-up.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- BackgroundJantchou, P., Mailhot, G., Ezri, J., Le Deist, F., Deslandres, C., & Delvin, E. (2014). P-102: Bioavailability and tolerance of high doses vitamin D in children with newly diagnosed Crohn's disease. Journal of Crohn's and Colitis, 8, S432. doi:10.1016/s1873-9946(14)50130-4
- Background: PubMed 24247650Jantchou P, Clavel-Chapelon F, Racine A, Kvaskoff M, Carbonnel F, Boutron-Ruault MC. High residential sun exposure is associated with a low risk of incident Crohn's disease in the prospective E3N cohort. Inflamm Bowel Dis. 2014 Jan;20(1):75-81. doi: 10.1097/01.MIB.0000436275.12131.4f.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prevost Jantchou, MD,PhD principal investigator
St. Justine's Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing vitamin D3 in people with Crohn Disease, run by Jantchou Prevost at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrollment stopped at 55 of 316 planned participants due to recruitment challenges related to the COVID-19 pandemic and funding constraints. All enrolled participants completed 52-week follow-up.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse (time frame: Within 52 weeks after randomization in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03999580, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.