Back to resultsNew Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges
Primary Purpose
Allergy
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Elemental E028 with added food allergens
Elemental E028
Sponsored by
About this trial
This is an interventional diagnostic trial for Allergy focused on measuring double-blind placebo-controlled food challenges, food allergy, food hypersensitivity, triangle test, validated recipes
Eligibility Criteria
Inclusion Criteria:
- Children belonging to one of two age groups: 7-8 years or 14-15 years
- No previous hypersensitivity reaction to the food to be tested
- Capacity to understand the test instructions and to participate in the test sessions
Exclusion Criteria:
- Children not belonging to one of the two age groups: 7-8 years or 14-15 years
- One or more previous hypersensitivity reaction to the food to be tested
- Unability to understand the test instructions and to participate in the test sessions
Sites / Locations
- Department of Clinical Sciences, pediatrics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Elemental E028 with added food allergens
Elemental E028
Arm Description
Outcomes
Primary Outcome Measures
Number of participants detecting sensorial differences between the active materials (containing the allergens cow's milk, hen's egg, soy, wheat or cod) and the placebo materials
The present study aimed to validate new recipes for low-dose double-blind placebo-controlled food challenges in school children, by assessing that no sensory differences between the active materials containing cow's milk, hen's egg, soy, wheat or cod, and the placebo materials could be detected by test panels.
Secondary Outcome Measures
Full Information
NCT ID
NCT01633840
First Posted
June 20, 2012
Last Updated
April 27, 2021
Sponsor
Christina West
Collaborators
The Västerbotten county council, State Government founding for Health Care research, Oskarsfonden, Nutricia, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01633840
Brief Title
New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges
Official Title
New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christina West
Collaborators
The Västerbotten county council, State Government founding for Health Care research, Oskarsfonden, Nutricia, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aimed to validate new recipes for cow's milk, hen's egg, soy, cod and wheat, to be used in blinded low-dose food challenges.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy
Keywords
double-blind placebo-controlled food challenges, food allergy, food hypersensitivity, triangle test, validated recipes
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
275 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elemental E028 with added food allergens
Arm Type
Active Comparator
Arm Title
Elemental E028
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Elemental E028 with added food allergens
Intervention Description
Test materials containing liquid vehicle (Elemental E028)with added food allergens (active)
Intervention Type
Other
Intervention Name(s)
Elemental E028
Intervention Description
Elemental E028 with no added food allergens
Primary Outcome Measure Information:
Title
Number of participants detecting sensorial differences between the active materials (containing the allergens cow's milk, hen's egg, soy, wheat or cod) and the placebo materials
Description
The present study aimed to validate new recipes for low-dose double-blind placebo-controlled food challenges in school children, by assessing that no sensory differences between the active materials containing cow's milk, hen's egg, soy, wheat or cod, and the placebo materials could be detected by test panels.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children belonging to one of two age groups: 7-8 years or 14-15 years
No previous hypersensitivity reaction to the food to be tested
Capacity to understand the test instructions and to participate in the test sessions
Exclusion Criteria:
Children not belonging to one of the two age groups: 7-8 years or 14-15 years
One or more previous hypersensitivity reaction to the food to be tested
Unability to understand the test instructions and to participate in the test sessions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina E West, MD, PhD
Organizational Affiliation
Umeå University Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Sciences, pediatrics
City
Umeå
ZIP/Postal Code
901 87
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
23590418
Citation
Winberg A, Nordstrom L, Strinnholm A, Nylander A, Jonsall A, Ronmark E, West CE. New validated recipes for double-blind placebo-controlled low-dose food challenges. Pediatr Allergy Immunol. 2013 May;24(3):282-7. doi: 10.1111/pai.12061.
Results Reference
background
Learn more about this trial
New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges
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