Bioavailability of Vitamin D in Children and Adolescents With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

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.
    

Intervention name(s): Vitamin D3 3000 UI daily; Vitamin D3 4000 UI daily
Intervention type(s): Drug; Drug
Intervention description(s): Vitamin D3 will be administered as an adjunct to corticosteroids or enteral nutrition at the doses of 3000 UI daily or 4000 UI daily; This arm is intended for those at diagnosis treated with Corticosteroid or in Remission
Other intervention name(s): Cholecalciferol; Cholecalciferol
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn; vitamin D; remission; inflammation; tolerance