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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR890 |
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Date of registration:
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08/02/2007 |
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Primary sponsor: |
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Public title:
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Influence of the dietary history in the prevention of coeliac disease: possibilities of induction of tolerance for gluten in genetic predisposed children.
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Scientific title:
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Influence of the dietary history in the prevention of coeliac disease: possibilities of induction of tolerance for gluten in genetic predisposed children. - PREVENTCD |
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Date of first enrolment:
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1/1/2007 |
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Target sample size:
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1000 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=890 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: [default]
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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M.L.
Mearin |
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Address:
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Leiden University Medical Centre
Dept. Of Pediatrics
PO box 9600
2300 RC
Leiden
The Netherlands |
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Telephone:
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Email:
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M.L.Mearin_Manrique@lumc.nl |
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Affiliation:
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Name:
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M.L.
Mearin |
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Address:
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Leiden University Medical Centre
Dept. Of Pediatrics
PO box 9600
2300 RC
Leiden
The Netherlands |
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Telephone:
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Email:
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M.L.Mearin_Manrique@lumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1.Infant born during the study with a first degree relative (parent or sibling) with CD;
2.Informed consent for the study.
Exclusion criteria: 1. No informed consent;
2. Parents-guardians unable to understand the information necessary to give informed consent.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Coeliac disease , Breastfeeding , Early feeding , Genetic predisposition , Human leukocyte antigen (HLA), Food intervention
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Intervention(s)
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In the family study:
1. The ?intervention group? will get a small amount of gluten (1 gram of wheat flour= 100mg gliadin) during the period of breastfeeding from the age of 4 months for 8 weeks.
2. The ?control group' (placebo) will get milk sugar powder (1gram of lactose) during the period of breastfeeding from the age of 4 months for 8 weeks.
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Primary Outcome(s)
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A reduction of 50% of CD among the intervention group at the age of 3 years will be considered as an effective prevention.
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Secondary Outcome(s)
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If the proposed early dietary intervention results in effective prevention of CD:
1. Development of new European guidelines for early nutrition in order to prevent the disease;
2. Identification of the influence of early feeding on the development of coeliac disease in relation with immunological and genetical factors.
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Secondary ID(s)
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ISRCTN74582487
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N/A
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Source(s) of Monetary Support
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European Commission
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