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Main
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Note: This record shows only 22 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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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02825069 |
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Date of registration:
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28/06/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study on the Induction of Food Tolerance in Babies
INTO |
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Scientific title:
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Randomized Controlled Study on the Induction of Food Tolerance in Babies |
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Date of first enrolment:
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March 2014 |
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Target sample size:
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1214 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02825069 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Finland
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Contacts
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Name:
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Petri Kulmala, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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PEDEGO-Research Unit and Medical Research Center Oulu, University of Oulu and Oulu University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All newborn babies attending local Child Health Clinics
Exclusion Criteria:
- Parents unable to communicate with Finnish language (questionnaires in Finnish)
Age minimum:
N/A
Age maximum:
1 Month
Gender:
All
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Health Condition(s) or Problem(s) studied
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Food Hypersensitivity
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Intervention(s)
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Other: Early introduction of solid foods
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Primary Outcome(s)
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The number of patients with dietary restrictions due to food related symptoms
[Time Frame: By the age of one year]
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Secondary Outcome(s)
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Family experienced distress based on questionnaire
[Time Frame: By the age of one year]
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The number of children with parent-reported atopic eczema
[Time Frame: By the age of one year]
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The number of health care contacts due to food related symptoms
[Time Frame: By the age of one year]
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The number of children with doctor-diagnosed atopic eczema
[Time Frame: By the age of one year]
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The number of children with doctor-diagnosed food allergies
[Time Frame: By the age of one year]
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The number of children with parent-reported food allergies
[Time Frame: By the age of one year]
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Secondary ID(s)
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Baby-INTO
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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