MedTrace Logo

The Vitamin D in Pediatric Crohn's Disease

NCT02186275 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-09-22

No results posted yet for this study

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

Interventions

DRUG

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

* 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.

DRUG

Vitamin D3 800 UI/day then 800 UI/day

* 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

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Prevost Jantchou, MD · St. Justine's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2019-12-20
Completion
2019-12-20

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02186275 on ClinicalTrials.gov