Study on the Induction of Food Tolerance in Babies
INTO
Randomized Controlled Study on the Induction of Food Tolerance in Babies
1 other identifier
interventional
1,214
1 country
1
Brief Summary
This general population based, randomized controled trial aims at answering two major hypotheses: First, systematic early introduction of solid foods decreases the incidence of food allergy and dietary restrictions by the age of one year. Second, stimulation with the symptom-eliciting food rather than avoidance will induce tolerance in babies with non-severe allergic symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
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
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 28, 2016
CompletedFirst Posted
Study publicly available on registry
July 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedOctober 27, 2017
October 1, 2017
3.6 years
June 28, 2016
October 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The number of patients with dietary restrictions due to food related symptoms
By the age of one year
Secondary Outcomes (6)
The number of children with doctor-diagnosed food allergies
By the age of one year
The number of children with parent-reported food allergies
By the age of one year
The number of children with doctor-diagnosed atopic eczema
By the age of one year
The number of children with parent-reported atopic eczema
By the age of one year
The number of health care contacts due to food related symptoms
By the age of one year
- +1 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALEarly introduction of solid foods starting at the age of 4 months, with foodstuff from all major groups in diet by the age of 6 months (vegetables and fruits, wheat and other grains, meat, fish, egg, dairy products). Babies presenting with mild symptoms are encouraged to continue the symptom-eliciting food.
Control group
NO INTERVENTIONFamilies are advised to follow the official Finnish Nutrition Recommendations, including exclusive breastfeeding until the age of 6 months.
Interventions
Eligibility Criteria
You may qualify if:
- All newborn babies attending local Child Health Clinics
You may not qualify if:
- Parents unable to communicate with Finnish language (questionnaires in Finnish)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PEDEGO Research Unit, University of Oulu and Oulu University Hospital
Oulu, 90014, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Petri Kulmala, MD, PhD
PEDEGO-Research Unit and Medical Research Center Oulu, University of Oulu and Oulu University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Clinical lecturer
Study Record Dates
First Submitted
June 28, 2016
First Posted
July 7, 2016
Study Start
March 1, 2014
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
October 27, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share