Bioavailability of Vitamin D in Children and Adolescents With Crohn's Disease.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Number of participants with adverse events after one month
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 *
Arms & Interventions
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.
Intervention: Vitamin D3 3000 UI daily (Drug)
Corticosteroids + Vitamin D3 4000 UI
Corticosteroids (1mg/kg/day) associated with vitamin D3 4000 UI daily and calcium 1000 mg daily for one month
Intervention: Vitamin D3 4000 UI daily (Drug)
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.
Intervention: Vitamin D3 4000 UI daily (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Decrease of inflammatory parameters(Baseline and 1 month)
- Immunological changes(Baseline and 1 month)
- Bioavailability(Baseline, after 24 h and then weekly for one month)
Investigators
Jantchou Prevost
Professor
St. Justine's Hospital