The Vitamin D in Pediatric Crohn's Disease

NCT02186275 | Completed Phase 3 DMC

• 1 other identifier: JP2014
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 10

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 with newly diagnosed Crohn's disease (CD).

Conditions

Crohn's Disease

Keywords

Crohn; vitamin D; remission; inflammation; tolerance

Outcome Measures

Primary Outcomes (1)

• Occurrence of at least one relapse within 52 weeks after randomization in the trial.

  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) \> 30. 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 inclusion in the study

Secondary Outcomes (5)

• the lapse of time from randomization to first relapse

  from randomization to first relapse

• the number of relapses per patient per year

  within 52 weeks after randomization in the trial

• the duration of corticotherapy

  between randomization and 52 weeks later

• The number of CD related hospitalizations

  between randomization and 52 weeks later

• The quality of life

  at 26 weeks and 52 weeks

Other Outcomes (2)

• Change in the level of physical activities

  between randomization and 52 weeks later

• Changes in bone mineral density

  between randomization and 52 weeks later

Study Arms (2)

Vitamin D3 3000 or 4000 UI/day then 2,000 UI/day

EXPERIMENTAL

3000 UI or 4,000 UI/day as induction therapy (according to weight) for 4 weeks then 2,000 UIday 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: 3000 or 4000 UI/day then 2,000 UI/day

Vitamin D3 800 UI/day then 800 UI/day

ACTIVE COMPARATOR

800 UI/day as induction therapy for 4 weeks, then 800 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 800 UI/day then 800 UI/day

Interventions

Vitamin D3: 3000 or 4000 UI/day then 2,000 UI/day DRUG

* Weight at inclusion \< 40 kg : 3 capsules of 1000 UI per day at induction and 2 capsules of 1000 UI per day at maintenance. * Weight at inclusion ≥ 40 kg : 4 capsules of 1000 UI per day at induction and 2 capsules of 1000 UI per day at maintenance.

Also known as: Cholecalciferol

Vitamin D3 3000 or 4000 UI/day then 2,000 UI/day

Vitamin D3 800 UI/day then 800 UI/day DRUG

* Weight \< 40 kg: 2 capsules of 400 UI per day and 1 capsules of placebo at induction and 2 capsules of 400 UI per day at maintenance * Weight ≥ 40 kg: 2 capsules of 400 UI per day and 2 capsules of placebo at induction and 2 capsules of 400 UI per day at maintenance

Also known as: Cholecalciferol

Vitamin D3 800 UI/day then 800 UI/day

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age at randomization between 9 and 18 years inclusively
• Interval between diagnosis and randomization between 2 weeks and 6 months after the diagnosis
• Concurrent treatment with corticosteroids and/or enteral nutrition and/or thiopurines (azathioprine, 6-mercaptopurine) and/or methotrexate and/or 5-aminosalicylic acid (5-ASA) and/or TNF-α inhibitors (Infliximab, Adalimumab).

You may not qualify if:

• Patient diagnosed with severe complex perianal fistulizing CD (defined as the presence at diagnosis of a high intersphincteric, transsphincteric, extrasphincteric, or suprasphincteric complex perianal fistula)
• Known chronic liver cholestasis (defined by an elevation of conjugated bilirubin and/or gamma glutamyl transferase \> 3 upper limit normal)
• Known renal dysfunction requiring chronic dialysis or creatinine ≥ 100 micromol/L.
• Known congenital bone disease
• Known cystic fibrosis or other exocrine pancreatic insufficiency.
• Currently treated with anticonvulsants metabolized through cytochrome P-450
• Unable to take oral capsule form.

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (10)

Edmonton Clinic Health Academy

Edmonton, Alberta, T6G 1C9, Canada

Location

University of British Columbia

Vancouver, British Columbia, V6H 3V4, Canada

Location

Health Science Center Pediatric

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Janeway Children's Health Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

McMaster University

Hamilton, Ontario, L8S4L8, Canada

Location

Hospital for Sick Childrens

Toronto, Ontario, M5G 1X8, Canada

Location

Montreal Children's Hospital (Montreal).

Montreal, Quebec, H3H 1P3, Canada

Location

Ste-Justine hospital

Montreal, Quebec, H3T1C5, Canada

Location

Centre Hospitalier Universitaire Laval

Québec, G1V 4G2, Canada

Location

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

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 10, 2014
• Study Start: February 1, 2016
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: September 22, 2020

Record last verified: 2020-09

Locations

CA (10)