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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by St. Justine's Hospital
Sponsor:
Information provided by (Responsible Party):
Jantchou Prevost, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT01692808
First received: September 17, 2012
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Drug: Vitamin D3 3000 UI daily
Drug: Vitamin D3 4000 UI daily
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bioavailability of Vitamin D in Children and Adolescents With Crohn's Disease.

Resource links provided by NLM:


Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:
  • Number of participants with adverse events after one month [ Time Frame: up to 1 month ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Decrease of inflammatory parameters [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]
    Evaluate the change from baseline in effect in blood and fecal inflammatory parameters (erythrocyte sedimentation rate, C-reactive protein, faecal Calprotectin).

  • Immunological changes [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]
    Evaluate the change from baseline in immunological parameters (lymphocytes CD3, CD4, CD8, Treg and iNKT, proliferation and activation of CD4 and CD8).

  • Bioavailability [ Time Frame: Baseline, after 24 h and then weekly for one month ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Cholecalciferol

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.
  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 *
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692808

Contacts
Contact: Prevost Jantchou, MD, PhD 5143454999

Locations
Canada, Quebec
Mother-child university hospital Recruiting
Montreal, Quebec, Canada, H3T1C5
Contact: Prevost Jantchou, MD, PhD         
Principal Investigator: Prevost Jantchou, MD, PhD         
Sub-Investigator: Genevieve Mailhot, PhD, DtP         
Sub-Investigator: Edgar Delvin, BSc MSC PhD         
Sub-Investigator: Françoise Le Deist, MD, PhD         
Sub-Investigator: Colette Deslandres, MD         
Sub-Investigator: Martha Dirks, MD         
Sponsors and Collaborators
St. Justine's Hospital
Investigators
Principal Investigator: Prevost Jantchou, MD, PHD mother-child university hospital Ste. Justine Montreal-Canada
  More Information

Publications:
Responsible Party: Jantchou Prevost, Professor, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT01692808     History of Changes
Other Study ID Numbers: JP2012042
Study First Received: September 17, 2012
Last Updated: June 20, 2014
Health Authority: Canada: Health Canada

Keywords provided by St. Justine's Hospital:
Crohn
vitamin D
remission
inflammation
tolerance

Additional relevant MeSH terms:
Vitamin D
Vitamins
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Cholecalciferol
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 29, 2014