New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges

Allergy Clinical Trial

Official title:

New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01633840
• Other study ID #: 06-089M
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Allergy
• Hypersensitivity

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.