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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01633840
Other study ID # 06-089M
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2008
Est. completion date December 2010

Study information

Verified date April 2021
Source Umeå University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 275
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 15 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Elemental E028 with added food allergens
Test materials containing liquid vehicle (Elemental E028)with added food allergens (active)
Elemental E028
Elemental E028 with no added food allergens

Locations

Country Name City State
Sweden Department of Clinical Sciences, pediatrics Umeå

Sponsors (5)

Lead Sponsor Collaborator
Christina West Nutricia, Inc., Oskarsfonden, State Government founding for Health Care research, The Västerbotten county council

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Winberg A, Nordström L, Strinnholm Å, Nylander A, Jonsäll A, Rönmark 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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