Recruiting
Phase 3

Vitamin D

Sponsor:

Jantchou Prevost

Code:

NCT03999580

Conditions

Crohn Disease

Eligibility Criteria

Sex: All

Age: 4 - 18

Healthy Volunteers: Not accepted

Interventions

vitamin D3

Study Details

Brief 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).

Conditions

Crohn Disease

Study ID

NCT03999580

Start date

Feb 7, 2020

Status verified date

Sep, 2020

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age at randomization between 4 and 17 years inclusively
2. Pediatric Crohn's Disease Activity Index (PCDAI) ≤ 10 with no clinical symptoms (abdominal pain or blood in the stool) at inclusion
3. Receiving a stable dose for at least 4 weeks of any of the following drugs: Thiopurines, Methotrexate, or TNF-α inhibitors (Infliximab/Adalimumab)
4. Dosage of fecal calprotectin lower than 250 µg/g stool at inclusion.

Exclusion Criteria:

1. History of surgery resulting in a permanent colostomy or ileostomy (because of the inability to calculate PCDAI at baseline)
2. Patients who have already been included in the pilots vitamin D trials
3. Patients actively enrolled in other CD drug trials.

Study Design

Enrollment

316 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental Arm:

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).

active comparator: Control Arm:

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)).

Interventions

vitamin D3

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

Primary outcome measure

  • Relapse [ Time Frame: Within 52 weeks after randomization in the study ]

Central Contacts and Locations

Central contacts

Prevost Jantchou, MD, PhD

514-345-4931prevost.jantchou@umontreal.ca

Saly El Salti, MSc

514-345-4931saly.elsalti@recherche-ste-justine.qc.ca

Locations

CHU Sainte-Justine

Recruiting

Montréal, Quebec, Canada, H3T 1C5

Contacts

Prévost Jantchou, MD, PhD

514-345-4931prevost.jantchou@umontreal.ca

More Information

Sponsor

Jantchou Prevost

Last update posted

Sep 23, 2020

Last verified

Sep, 2020

Keywords

  • Crohn
  • vitamin D
  • remission
  • inflammation
  • tolerance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jantchou Prevost on 2020-09-23.