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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01633840
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : July 4, 2012
Sponsor:
Collaborators:
The Västerbotten county council
State Government founding for Health Care research
Oskarsfonden
Nutricia, Inc.
Information provided by (Responsible Party):
Christina West, Umeå University

Tracking Information
First Submitted Date  ICMJE June 20, 2012
First Posted Date  ICMJE July 4, 2012
Last Update Posted Date July 4, 2012
Study Start Date  ICMJE September 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges
Official Title  ICMJE New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Allergy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Elemental E028 with added food allergens
    Intervention: Other: Elemental E028 with added food allergens
  • Placebo Comparator: Elemental E028
    Intervention: Other: Elemental E028
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2012)
275
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01633840
Other Study ID Numbers  ICMJE 06-089M
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christina West, Umeå University
Study Sponsor  ICMJE Christina West
Collaborators  ICMJE
  • The Västerbotten county council
  • State Government founding for Health Care research
  • Oskarsfonden
  • Nutricia, Inc.
Investigators  ICMJE
Principal Investigator: Christina E West, MD, PhD Umeå University Sweden
PRS Account Umeå University
Verification Date June 2012

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