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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

Age at randomization between 4 and 17 years inclusively

Must not have

History of surgery resulting in a permanent colostomy or ileostomy (because of the inability to calculate PCDAI at baseline)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 26 and week 52

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Approved for 5 Other Conditions

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My Crohn's disease is mild with no current symptoms.

Select...

I am between 4 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a permanent colostomy or ileostomy due to surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 26 and week 52

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Relapse

Secondary study objectives

Improvement of the Quality of life

Lapse of time from randomization to first relapse

Number of hospitalizations per year

+1 more

Other study objectives

Change in the level of physical activities

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 3Eligibility criteria met