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CompletedNCT01633840Updated Apr 30, 2021

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

An interventional study of Elemental E028 with added food allergens and Elemental E028 in Allergy, sponsored by Christina West. Completed at 1 site in Sweden. Open to participants aged 8 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-30.

Sponsored by Christina West · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
275
Allocation
Randomized
Ages
8 Years to 15 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Allergy

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Keywords

  • double-blind placebo-controlled food challenges
  • food allergy
  • food hypersensitivity
  • triangle test
  • validated recipes
03

In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 275 is above the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.

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Lead sponsor

This is the only study on the registry with Christina West as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
275 participants (actual)

Study arms

  • Active comparator
    Elemental E028 with added food allergens

    Other: Elemental E028 with added food allergens

  • Placebo comparator
    Elemental E028

    Other: Elemental E028

Interventions

  • OtherElemental E028 with added food allergens

    Test materials containing liquid vehicle (Elemental E028)with added food allergens (active)

  • OtherElemental E028

    Elemental E028 with no added food allergens

06

What researchers measure

Primary outcomes

  1. 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.

07

Study locations

1 site
  • Department of Clinical Sciences, pediatrics
    Umeå, 901 87, Sweden
08

References and documents

Publications

  • Winberg A, Nordstrom L, Strinnholm A, Nylander A, Jonsall A, Ronmark 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. PubMed 23590418 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01633840
Lead sponsor
Christina West
Collaborators
The Västerbotten county council, State Government founding for Health Care research, Oskarsfonden, Nutricia, Inc.
Responsible party
Christina West (MD, PhD, Umeå University) — Sponsor-investigator
First posted
Jul 4, 2012
Start date
Sep 2008
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Apr 30, 2021

Study contacts

Christina E West, MD, PhD
principal investigator · Umeå University Sweden

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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