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Study on the Induction of Food Tolerance in Babies (INTO)

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ClinicalTrials.gov Identifier: NCT02825069
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Petri Kulmala, University of Oulu

Tracking Information
First Submitted Date  ICMJE June 28, 2016
First Posted Date  ICMJE July 7, 2016
Last Update Posted Date October 27, 2017
Actual Study Start Date  ICMJE March 2014
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2016)
The number of patients with dietary restrictions due to food related symptoms [ Time Frame: By the age of one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02825069 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2016)
  • The number of children with doctor-diagnosed food allergies [ Time Frame: By the age of one year ]
  • The number of children with parent-reported food allergies [ Time Frame: By the age of one year ]
  • The number of children with doctor-diagnosed atopic eczema [ Time Frame: By the age of one year ]
  • The number of children with parent-reported atopic eczema [ Time Frame: By the age of one year ]
  • The number of health care contacts due to food related symptoms [ Time Frame: By the age of one year ]
  • Family experienced distress based on questionnaire [ Time Frame: By the age of one year ]
    The subjective estimate of the distress (multiple choice scaled questions) related to food induced symptoms in the baby
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study on the Induction of Food Tolerance in Babies
Official Title  ICMJE Randomized Controlled Study on the Induction of Food Tolerance in Babies
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.
Detailed Description All new born babies living in the city of Oulu are recruited to the study (n=1380) at their first health nurse visit (at or before 1 month of age) in the local primary care child health clinics. Families in the intervention group will get an instruction booklet including information on early systematic 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). Furthermore, the booklet includes information and instructions on food related symptoms and atopic eczema. Babies with mild symptoms are encouraged to continue the symptom-eliciting food. All families fill out monthly internet-based questionnaires on food diary, symptoms, diagnoses and health care visits until the age of 1 year.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Food Hypersensitivity
Intervention  ICMJE Other: Early introduction of solid foods
Early introduction of solid foods
Study Arms  ICMJE
  • Experimental: Intervention group
    Early 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.
    Intervention: Other: Early introduction of solid foods
  • No Intervention: Control group
    Families are advised to follow the official Finnish Nutrition Recommendations, including exclusive breastfeeding until the age of 6 months.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2017)
1214
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2016)
1380
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All newborn babies attending local Child Health Clinics

Exclusion Criteria:

  • Parents unable to communicate with Finnish language (questionnaires in Finnish)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Month   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02825069
Other Study ID Numbers  ICMJE Baby-INTO
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Petri Kulmala, University of Oulu
Study Sponsor  ICMJE University of Oulu
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Petri Kulmala, MD, PhD PEDEGO-Research Unit and Medical Research Center Oulu, University of Oulu and Oulu University Hospital
PRS Account University of Oulu
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP