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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

June 20, 2012
June 29, 2012
September 2008
December 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01633840 on ClinicalTrials.gov Archive Site
 
 
 
 
 
New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges
New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges

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.
 
Interventional
 
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Allergy
  • Other: Elemental E028 with added food allergens
    Test materials containing liquid vehicle (Elemental E028)with added food allergens (active)
  • Other: Elemental E028
    Elemental E028 with no added food allergens
  • Active Comparator: Elemental E028 with added food allergens
    Intervention: Other: Elemental E028 with added food allergens
  • Placebo Comparator: Elemental E028
    Intervention: Other: Elemental E028
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
275
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
8 Years to 15 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01633840
06-089M
No
Christina West, Umeå University
Christina West
  • The Västerbotten county council
  • State Government founding for Health Care research
  • Oskarsfonden
  • Nutricia AB
Principal Investigator: Christina E West, MD, PhD Umeå University Sweden
Umeå University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP