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

This study has been completed.
Sponsor:
Collaborators:
The Västerbotten county council
State Government founding for Health Care research
Oskarsfonden
Nutricia AB
Information provided by (Responsible Party):
Christina West, Umeå University
ClinicalTrials.gov Identifier:
NCT01633840
First received: June 20, 2012
Last updated: June 29, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Allergy
 Other: Elemental E028 with added food allergens
Other: Elemental E028

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Umeå University:

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 [ Designated as safety issue: No ]
    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.


Enrollment: 275
Study Start Date: September 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Elemental E028 with added food allergens Other: Elemental E028 with added food allergens
Test materials containing liquid vehicle (Elemental E028)with added food allergens (active)
Placebo Comparator: Elemental E028 Other: Elemental E028
Elemental E028 with no added food allergens

  Eligibility

Ages Eligible for Study:   8 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633840

Locations
Sweden
Department of Clinical Sciences, pediatrics
Umeå, Sweden, 901 87
Sponsors and Collaborators
Christina West
The Västerbotten county council
State Government founding for Health Care research
Oskarsfonden
Nutricia AB
Investigators
Principal Investigator: Christina E West, MD, PhD Umeå University Sweden
  More Information

No publications provided

Responsible Party: Christina West, MD, PhD, Umeå University
ClinicalTrials.gov Identifier: NCT01633840     History of Changes
Other Study ID Numbers: 06-089M
Study First Received: June 20, 2012
Last Updated: June 29, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Umeå University:
double-blind placebo-controlled food challenges
food allergy
food hypersensitivity
triangle test
validated recipes

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 17, 2013