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

NCT03999580 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2020-09-23

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 diagnosed Crohn's disease (CD).

Conditions

  • Crohn Disease

Interventions

DRUG

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

Sponsors & Collaborators

  • Jantchou Prevost

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-02-07
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • Canada

Study Locations

More Related Trials

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 NCT03999580 on ClinicalTrials.gov