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Vitamin D3 for Crohn's Disease (ViDiPeC-2 Trial)

Phase 3
Recruiting
Led By Prevost Jantchou, MD,PhD
Research Sponsored by Jantchou Prevost
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 26 and week 52
Awards & highlights

ViDiPeC-2 Trial Summary

This trial is testing whether adding vitamin D to the usual treatment for Crohn's disease can improve symptoms and quality of life.

Who is the study for?
This trial is for children aged 4-17 with mild Crohn's Disease, showing no symptoms like abdominal pain or blood in stool. They must be on a stable dose of certain medications (Thiopurines, Methotrexate, TNF-α inhibitors) and have low fecal calprotectin levels. Kids who've had surgery resulting in colostomy/ileostomy, participated in previous vitamin D trials, or are in other drug trials can't join.Check my eligibility
What is being tested?
The ViDiPeC-2 study tests if adding vitamin D to standard treatments helps kids with Crohn's Disease have fewer relapses and improves their quality of life and physical activity levels.See study design
What are the potential side effects?
Vitamin D3 is generally safe but may cause side effects such as nausea, vomiting, constipation, weakness or more serious ones like kidney stones if taken at high doses over long periods.

ViDiPeC-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My Crohn's disease is mild with no current symptoms.
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I have been on a steady dose of Thiopurines, Methotrexate, or TNF-α inhibitors for at least 4 weeks.
Select...
My Crohn's disease is mild with no current symptoms like abdominal pain or blood in stool.
Select...
I am between 4 and 17 years old.
Select...
I am between 4 and 17 years old.

ViDiPeC-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 26 and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 26 and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relapse
Secondary outcome measures
Improvement of the Quality of life
Lapse of time from randomization to first relapse
Number of hospitalizations per year
+1 more
Other outcome measures
Change in the level of physical activities

ViDiPeC-2 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Arm:Experimental Treatment1 Intervention
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).
Group II: Control Arm:Active Control1 Intervention
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)).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cholecalciferol
FDA approved

Find a Location

Who is running the clinical trial?

Jantchou PrevostLead Sponsor
Prevost Jantchou, MD,PhDPrincipal InvestigatorSt. Justine's Hospital

Media Library

vitamin D3 Clinical Trial Eligibility Overview. Trial Name: NCT03999580 — Phase 3
Crohn's Disease Research Study Groups: Control Arm:, Experimental Arm:
Crohn's Disease Clinical Trial 2023: vitamin D3 Highlights & Side Effects. Trial Name: NCT03999580 — Phase 3
vitamin D3 2023 Treatment Timeline for Medical Study. Trial Name: NCT03999580 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what conditions is vitamin D3 commonly prescribed?

"Vitamin D3 is not only used to manage calcium intake, but can also help with fractures, spine fractures, and post menopausal women."

Answered by AI

How many subjects are being recruited for this research?

"A total of 316 individuals that meet the pre-determined inclusion criteria are required for this clinical trial. These patients can be recruited from multiple hospitals, including Stollery Children's Hospital in Edmonton, Alberta and Montreal Children's Hospital in London, Ontario."

Answered by AI

Will this research opportunity be available to middle-aged patients?

"Based on the inclusion criteria, it appears that this clinical trial is for patients aged 4-18. There are 81 studies for patients under 18 and 222 for patients over 65."

Answered by AI

What is the precedent for using vitamin D3 in medical research?

"There are 37 clinical trials studying vitamin D3, 15 of which are in Phase 3. Although many of these trials are based in Boston, Massachusetts, there are 171 locations across the United States running these trials."

Answered by AI

Are there any potential dangers to patients when they take vitamin D3?

"There is existing clinical data supporting the safety of vitamin D3, thus it received a score of 3."

Answered by AI

Are there any participating locations in North America for this research?

"This study is currently underway at Stollery Children's Hospital in Edmonton, Alberta; Montreal Children's Hospital in London, Ontario; and London Health Sciences Centre in Vancouver, British Columbia. Seven other locations are also participating."

Answered by AI
~62 spots leftby Mar 2025