Completed

Bioavailability of Vitamin D in Children and Adolescents With Crohn's Disease.

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What is being tested

Vitamin D3 3000 UI daily

+ Vitamin D3 4000 UI daily

+ Vitamin D3 4000 UI daily

Drug
Who is being recruted

Digestive System Diseases+6

+ Gastroenteritis

+ Gastrointestinal Diseases

From 10 to 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorSt. Justine's Hospital
Last updated: November 3, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

Background : Crohn's disease is a chronic inflammatory condition affecting all segments of the digestive tract from the mouth to the anus. This condition is associated with an increased risk of relapses throughout the course of the disease. Nearly 25% of patients with Crohn's disease are in the pediatric age range. Many epidemiological data are in favor of an increase incidence of pediatric Crohn's disease. Environmental factors could explain this increased incidence. Among them sunlight exposure and vitamin D deficiency have been suggested by many authors. Vitamin D, in addition to its action on bone metabolism, exerts an anti-inflammatory effect by modulating the innate and acquired immune system. The biological effect of high doses of vitamin D administered orally have not been extensively studied in children with Crohn's disease. In these patients, the absorption and bioavailability of vitamin D may be altered in relation with mucosal lesions. Objective : Thus our aim is to investigate the effect of high doses of vitamin D3 administered orally as an adjunct therapy to children with newly diagnosed pediatric Crohn diseases or children in remission. Methods : In this Prospective study 40 children will be enrolled and followed up for a duration of one month. The administration of vitamin D 3000 IU or 4000 IU per day will be considered as an adjunct to conventional therapy (steroids or enteral nutrition for patients at diagnosis or immunosuppressants for patients in remission). Analysis: Tolerance will be assessed during weekly visits by a brief questionnaire and blood tests. Efficacy will be assessed by monitoring the change in fecal and blood inflammatory markers. Change in the immunological status will be assessed by measuring the following parameters : T lymphocyte count CD3, CD4, CD8, and invariant Natural Killer T cell, Treg. Proliferation and activation of CD4 and CD8 T lymphocytes induced by anti-CD3 antibody activator (OKT3). The activation will be evaluated by dosing CD25 and the proliferation by the study of cell cycle after 3 days of culture of total blood culture. The culture supernatants will be collected and frozen for subsequent analysis of cytokines Th1 and Th2 (IFN, IL2, IL4, IL13) with Affymetrix method that allows simultaneous determination of multiples cytokines.

Principal SponsorSt. Justine's Hospital
Last updated: November 3, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 10 to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsInflammatory Bowel DiseasesCrohn DiseaseInflammation

Criteria

3 inclusion criteria required to participate
Age between 10 and 18 years

Crohn's disease diagnosed by usual clinical and endoscopic criteria

Recent (less than one week) blood test with results of : Albumin, sedimentation rate, hematocrit

4 exclusion criteria prevent from participating
Current intake of medications known to interfere with the metabolism of calcium, phosphate and vitamin D *

Disorders of phospho-calcic metabolism and vitamin D

Intake of vitamin D supplementation in the last three months prior to enrollment

Known renal or cardiac malformation

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

5 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

No Intervention
This group is one of the non interventional group. As enteral nutrition is one of the usual therapy of Crohn disease at diagnosis.

Group II

Experimental
Exclusive Enteral Nutrition + Vitamin D3 3000 UI daily for one month This arm will be one of the two experimental arms.

Group III

No Intervention
Corticosteroids (1mg/kg/day) associated with usual vitamin and calcium supplementation: vitamin D 800 IU of vitamin D3 + 1000 mg calcium per day) for one month

Group IV

Experimental
Corticosteroids (1mg/kg/day) associated with vitamin D3 4000 UI daily and calcium 1000 mg daily for one month

Group 5

Experimental
Vitamin D3 4000 UI /day . This arm is intended for those children in remission with or without immunosuppressant. Vitamin D will be administered in adjunction to usual therapy.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Mother-child university hospital

Montreal, CanadaOpen Mother-child university hospital in Google Maps
CompletedOne Study Center
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