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

November 2, 2015 updated by: Jantchou Prevost, St. Justine's Hospital

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

The purpose of this study is to determine if high doses of vitamin D3 administered orally as adjunct therapy to children with Crohn's disease could improve the outcome of the disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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:

  1. Tolerance will be assessed during weekly visits by a brief questionnaire and blood tests.
  2. Efficacy will be assessed by monitoring the change in fecal and blood inflammatory markers.

  3. 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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T1C5
        • Mother-child university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Known renal or cardiac malformation
  • Disorders of phospho-calcic metabolism and vitamin D
  • Intake of vitamin D supplementation in the last three months prior to enrollment
  • Current intake of medications known to interfere with the metabolism of calcium, phosphate and vitamin D *

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Exclusive Enteral Nutrition
This group is one of the non interventional group. As enteral nutrition is one of the usual therapy of Crohn disease at diagnosis.
Experimental: EEN + Vitamin D3 3000 UI daily
Exclusive Enteral Nutrition + Vitamin D3 3000 UI daily for one month This arm will be one of the two experimental arms.
Drug: Vitamin D3 3000 UI daily
Vitamin D3 will be administered as an adjunct to corticosteroids or enteral nutrition at the doses of 3000 UI daily or 4000 UI daily
Other Names:
  • Cholecalciferol
No Intervention: Corticosteroïd
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
Experimental: Corticosteroids + Vitamin D3 4000 UI
Corticosteroids (1mg/kg/day) associated with vitamin D3 4000 UI daily and calcium 1000 mg daily for one month
Drug: Vitamin D3 4000 UI daily
This arm is intended for those at diagnosis treated with Corticosteroid or in Remission
Other Names:
  • Cholecalciferol
Experimental: Vitamin D3 4000 UI
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.
Drug: Vitamin D3 4000 UI daily
This arm is intended for those at diagnosis treated with Corticosteroid or in Remission
Other Names:
  • Cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events after one month
Time Frame: up to 1 month

Tolerance will be assessed weekly by measuring clinical adverse events in relation with high blood level of 25 hydroxy vitamin D.

Biological measures will also be performed including : Circulating level of Calcium, phosphorus, PTH.
up to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease of inflammatory parameters
Time Frame: Baseline and 1 month
Evaluate the change from baseline in effect in blood and fecal inflammatory parameters (erythrocyte sedimentation rate, C-reactive protein, faecal Calprotectin).
Baseline and 1 month
Immunological changes
Time Frame: Baseline and 1 month
Evaluate the change from baseline in immunological parameters (lymphocytes CD3, CD4, CD8, Treg and iNKT, proliferation and activation of CD4 and CD8).
Baseline and 1 month
Bioavailability
Time Frame: Baseline, after 24 h and then weekly for one month
The bioavailability will be assessed by measuring the level of 25 hydroxy vitamin D at baseline then 24 hours after the first administration of vitamin D then weekly up to one month and compare this level to baseline.
Baseline, after 24 h and then weekly for one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Justine's Hospital

Investigators

  • Principal Investigator: Prevost Jantchou, MD, PHD, mother-child university hospital Ste. Justine Montreal-Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

September 17, 2012

First Submitted That Met QC Criteria

September 24, 2012

First Posted (Estimate)

September 25, 2012

Study Record Updates

Last Update Posted (Estimate)

November 3, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JP2012042

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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