The Vitamin D in Pediatric Crohn's Disease ( ViDiPeC-2 )

NCT03999580 | Unknown Phase 3 DMC

• 1 other identifier: MP-21-2019-2095
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 7

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

Keywords

Crohn; vitamin D; remission; inflammation; tolerance

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 52 weeks after randomization in the study

Secondary Outcomes (4)

• Lapse of time from randomization to first relapse

  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

  Within 52 weeks after randomization in the study

• Number of hospitalizations per year

  Between randomization and Week 52

• Improvement of the Quality of life

  At week 26 and week 52

Other Outcomes (1)

• Change in the level of physical activities

  Between randomization and 52 weeks

Study Arms (2)

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).

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)).

Drug: vitamin D3

Interventions

vitamin D3 DRUG

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

Also known as: cholecalciferol

Control Arm:; Experimental Arm:

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age at randomization between 4 and 17 years inclusively
• Receiving a stable dose for at least 4 weeks of any of the following drugs: Thiopurines, Methotrexate, or TNF-α inhibitors (Infliximab/Adalimumab)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jantchou Prevost: lead

Study Sites (7)

Stollery Children's Hospital

Edmonton, Alberta, T6G 1C9, Canada

NOT YET RECRUITING

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

NOT YET RECRUITING

Children's Hospital

Winnipeg, Manitoba, R3A 1S1, Canada

NOT YET RECRUITING

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

NOT YET RECRUITING

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

NOT YET RECRUITING

Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

NOT YET RECRUITING

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

Related Publications (2)

• 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

  BACKGROUND

• 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.

  PMID: 24247650 BACKGROUND

MeSH Terms

Conditions

Crohn Disease; Inflammation

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Prevost Jantchou, MD,PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prevost Jantchou, MD, PhD

CONTACT

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

Saly El Salti, MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The vitamin D will be donated by a pharmaceutical company. It will be dispensed in anonymized bottles with the content similar in color and taste in order to keep patients unaware of their allocation. We will implement a number of study maneuvers aimed at minimizing measurement biases. These include: (1) masking of the data; (2) documenting the use of major co-interventions such as other multivitamin supplements.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: 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).

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: February 7, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: September 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)