Bioavailability of Vitamin D in Children and Adolescents With Crohn's Disease
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2012
CompletedFirst Posted
Study publicly available on registry
September 25, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedNovember 3, 2015
November 1, 2015
2.1 years
September 17, 2012
November 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events after one 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 Outcomes (3)
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
Study Arms (5)
Exclusive Enteral Nutrition
NO INTERVENTIONThis group is one of the non interventional group. As enteral nutrition is one of the usual therapy of Crohn disease at diagnosis.
EEN + Vitamin D3 3000 UI daily
EXPERIMENTALExclusive Enteral Nutrition + Vitamin D3 3000 UI daily for one month This arm will be one of the two experimental arms.
Corticosteroïd
NO INTERVENTIONCorticosteroids (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
Corticosteroids + Vitamin D3 4000 UI
EXPERIMENTALCorticosteroids (1mg/kg/day) associated with vitamin D3 4000 UI daily and calcium 1000 mg daily for one month
Vitamin D3 4000 UI
EXPERIMENTALVitamin 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 \*
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mother-child university hospital
Montreal, Quebec, H3T1C5, Canada
Related Publications (2)
Jantchou P, Clavel-Chapelon F, Racine A, Kvaskoff M, Carbonnel F, Boutron-Ruault MC. High residential sun exposure is associated with a low risk of incident Crohn's disease in the prospective E3N cohort. Inflamm Bowel Dis. 2014 Jan;20(1):75-81. doi: 10.1097/01.MIB.0000436275.12131.4f.
PMID: 24247650BACKGROUNDNerich V, Jantchou P, Boutron-Ruault MC, Monnet E, Weill A, Vanbockstael V, Auleley GR, Balaire C, Dubost P, Rican S, Allemand H, Carbonnel F. Low exposure to sunlight is a risk factor for Crohn's disease. Aliment Pharmacol Ther. 2011 Apr;33(8):940-5. doi: 10.1111/j.1365-2036.2011.04601.x. Epub 2011 Feb 20.
PMID: 21332762RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prevost Jantchou, MD, PHD
mother-child university hospital Ste. Justine Montreal-Canada
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 17, 2012
First Posted
September 25, 2012
Study Start
October 1, 2012
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
November 3, 2015
Record last verified: 2015-11