AllergyNCT01633840
New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges
A study testing Elemental E028 with added food allergens and Elemental E028 in people with Allergy, run by Christina West at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy
- What is being tested?
- Elemental E028 with added food allergens and Elemental E028
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 275 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Allergy
- Being tested
- Elemental E028 with added food allergens, Elemental E028
- Keywords
- double-blind placebo-controlled food challenges, food allergy, food hypersensitivity, triangle test, validated recipes
- Medical subject headings
- Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elemental E028 with added food allergensOther
Test materials containing liquid vehicle (Elemental E028)with added food allergens (active)
Elemental E028Other
Elemental E028 with no added food allergens
| Study group | Role | What they receive |
|---|---|---|
| Elemental E028 with added food allergens | Active comparator | Not described Receives: Other: Elemental E028 with added food allergens |
| Elemental E028 | Placebo comparator | Not described Receives: Other: Elemental E028 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startSep 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christina West
- Sponsor type
- University, hospital or other
- Collaborators
- The Västerbotten county council, State Government founding for Health Care research, Oskarsfonden, Nutricia, Inc.
- Responsible party
- Sponsor-investigator, Christina West, Umeå University
- Investigators
- Christina E West, MD, PhD, Principal investigator, Umeå University Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633840
- Sponsor's protocol ID
- 06-089M
- Status last verified
- Apr 2021
- First submitted
- 20 Jun 2012
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges
- ClinicalTrials.gov ID
- NCT01633840
- Acronym / sponsor ID
- 06-089M
- Conditions
- Allergy
- Keywords
- double-blind placebo-controlled food challenges, food allergy, food hypersensitivity, triangle test, validated recipes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Christina WestUniversity, hospital or other
- Collaborators
- The Västerbotten county council, State Government founding for Health Care research, Oskarsfonden, Nutricia, Inc.
- Study start
- Sep 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 4 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elemental E028 with added food allergens | Active comparator | Other: Elemental E028 with added food allergens |
| Elemental E028 | Placebo comparator | Other: Elemental E028 |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elemental E028 with added food allergensTest materials containing liquid vehicle (Elemental E028)with added food allergens (active) | Other | Elemental E028 with added food allergens |
| Elemental E028Elemental E028 with no added food allergens | Other | Elemental E028 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Background: PubMed 23590418Winberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina E West, MD, PhD principal investigator
Umeå University Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elemental E028 with added food allergens and Elemental E028 in people with Allergy, run by Christina West at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01633840, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.