New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges
1 other identifier
interventional
275
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2008
Typical duration 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
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 20, 2012
CompletedFirst Posted
Study publicly available on registry
July 4, 2012
CompletedApril 30, 2021
April 1, 2021
2.2 years
June 20, 2012
April 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
Elemental E028 with added food allergens
ACTIVE COMPARATORElemental E028
PLACEBO COMPARATORInterventions
Test materials containing liquid vehicle (Elemental E028)with added food allergens (active)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Christina Westlead
- The Västerbotten county councilcollaborator
- State Government founding for Health Care researchcollaborator
- Oskarsfondencollaborator
- Nutricia, Inc.collaborator
Study Sites (1)
Department of Clinical Sciences, pediatrics
Umeå, 901 87, Sweden
Related Publications (1)
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.
PMID: 23590418BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina E West, MD, PhD
Umeå University Sweden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 20, 2012
First Posted
July 4, 2012
Study Start
September 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
April 30, 2021
Record last verified: 2021-04