Crohn's DiseasePhase 2NCT01692808
Bioavailability of Vitamin D in Children and Adolescents With Crohn's Disease
A Phase 2 study testing Vitamin D3 3000 UI daily and Vitamin D3 4000 UI daily in people with Crohn's Disease, run by St. Justine's Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Vitamin D3 3000 UI daily and Vitamin D3 4000 UI daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to Nov 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 *
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- Tolerance will be assessed during weekly visits by a brief questionnaire and blood tests.
- Efficacy will be assessed by monitoring the change in fecal and blood inflammatory markers.
- 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.
- Conditions
- Crohn's Disease
- Being tested
- Vitamin D3 3000 UI daily, Vitamin D3 4000 UI daily
- Keywords
- Crohn, vitamin D, remission, inflammation, tolerance
- Medical subject headings
- Crohn Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 3000 UI dailyDrug
Also called Cholecalciferol
Vitamin D3 will be administered as an adjunct to corticosteroids or enteral nutrition at the doses of 3000 UI daily or 4000 UI daily
Vitamin D3 4000 UI dailyDrug
Also called Cholecalciferol
This arm is intended for those at diagnosis treated with Corticosteroid or in Remission
| Study group | Role | What they receive |
|---|---|---|
| Exclusive Enteral Nutrition | No intervention | This 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 | Experimental | Exclusive Enteral Nutrition + Vitamin D3 3000 UI daily for one month This arm will be one of the two experimental arms. Receives: Drug: Vitamin D3 3000 UI daily |
| Corticosteroïd | No intervention | 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 |
| Corticosteroids + Vitamin D3 4000 UI | Experimental | Corticosteroids (1mg/kg/day) associated with vitamin D3 4000 UI daily and calcium 1000 mg daily for one month Receives: Drug: Vitamin D3 4000 UI daily |
| Vitamin D3 4000 UI | Experimental | 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. Receives: Drug: Vitamin D3 4000 UI daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 month
Secondary outcomes (3)
Decrease of inflammatory parameters
Evaluate the change from baseline in effect in blood and fecal inflammatory parameters (erythrocyte sedimentation rate, C-reactive protein, faecal Calprotectin).
Measured: Baseline and 1 month
Immunological changes
Evaluate the change from baseline in immunological parameters (lymphocytes CD3, CD4, CD8, Treg and iNKT, proliferation and activation of CD4 and CD8).
Measured: Baseline and 1 month
Bioavailability
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.
Measured: Baseline, after 24 h and then weekly for one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jantchou Prevost, St. Justine's Hospital
- Investigators
- Prevost Jantchou, MD, PHD, Principal investigator, mother-child university hospital Ste. Justine Montreal-Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692808
- Sponsor's protocol ID
- JP2012042
- Status last verified
- Nov 2015
- First submitted
- 17 Sep 2012
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24247650Nerich 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.
PubMed 21332762
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Vitamin D in Children and Adolescents With Crohn's Disease.
- ClinicalTrials.gov ID
- NCT01692808
- Acronym / sponsor ID
- JP2012042
- Conditions
- Crohn's Disease
- Keywords
- Crohn, vitamin D, remission, inflammation, tolerance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Tolerance will be assessed during weekly visits by a brief questionnaire and blood tests.
- Efficacy will be assessed by monitoring the change in fecal and blood inflammatory markers.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Exclusive Enteral Nutrition | No intervention | –This 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 | Experimental | Drug: Vitamin D3 3000 UI dailyExclusive Enteral Nutrition + Vitamin D3 3000 UI daily for one month This arm will be one of the two experimental arms. |
| Corticosteroïd | No intervention | –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 |
| Corticosteroids + Vitamin D3 4000 UI | Experimental | Drug: Vitamin D3 4000 UI dailyCorticosteroids (1mg/kg/day) associated with vitamin D3 4000 UI daily and calcium 1000 mg daily for one month |
| Vitamin D3 4000 UI | Experimental | Drug: Vitamin D3 4000 UI dailyVitamin 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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 *
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 3000 UI dailyAlso: CholecalciferolVitamin D3 will be administered as an adjunct to corticosteroids or enteral nutrition at the doses of 3000 UI daily or 4000 UI daily | Drug | EEN + Vitamin D3 3000 UI daily |
| Vitamin D3 4000 UI dailyAlso: CholecalciferolThis arm is intended for those at diagnosis treated with Corticosteroid or in Remission | Drug | Corticosteroids + Vitamin D3 4000 UI, Vitamin D3 4000 UI |
Primary outcome
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.
3 secondary outcomes
Decrease of inflammatory parameters
Time frame: Baseline and 1 month
Immunological changes
Time frame: Baseline and 1 month
Bioavailability
Time frame: Baseline, after 24 h and then weekly for one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
- Background: PubMed 24247650Jantchou 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.
- Results publication: PubMed 21332762Nerich 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.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prevost Jantchou, MD, PHD principal investigator
mother-child university hospital Ste. Justine Montreal-Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D3 3000 UI daily and Vitamin D3 4000 UI daily in people with Crohn's Disease, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events after one month (time frame: up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01692808, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2015.