AzTrials
AzTrials

Food AllergyOmega-TreatNCT01473823

Treatment of IgE Associated Eczema With Omega-3 Long Chain Polyunsaturated Fatty Acids in Infancy and the Development of Bronchial Asthma in Childhood

A study testing Omega-3 LCPUFA in people with Food Allergy and Eczema, run by Ostergotland County Council, Sweden at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Although some causal factors in allergy development such as allergen exposure and environmental pollution have decreased during recent years, the incidence of the allergic diseases has increased in the Western world. Read more about this study

Who is it for?
Ages 3 to 12 months
Conditions the study is for
Food Allergy, Eczema, Sensitisation
What is being tested?
Omega-3 LCPUFA
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
1 siteSweden
Study dates
Jan 2012to Dec 2020
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 3 to 12 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Eczema and sensitisation to food allergens

Who cannot join

  • Fish allergy within family

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Allergicentrum

    Linköping

Other trials in Sweden

About this study

Although some causal factors in allergy development such as allergen exposure and environmental pollution have decreased during recent years, the incidence of the allergic diseases has increased in the Western world. Since the genetic predisposition to develop allergies cannot change in such a short time it is conceivable that, instead of the emerging of some new and unknown risk factors, some protective factors seem to have disappeared in the Western world.

Allergic disease is a tendency to develop allergies to allergens in the surrounding environment. The most common symptoms are eczema and food allergy in the early life, bronchial asthma (AB) later in childhood and allergic rhino conjunctivitis (ARC) during school age and adolescence, the so-called allergic march. Some person may develop only one, but others some or all of the symptoms. Inheritance, environment and allergen exposure are important factors affecting this march but there are important factors that predict later development of diseases. Sensitization to egg (positive skin prick test or specific IgE to egg in the serum) combined with skin problems in infancy predispose strongly to the development of allergic asthma in later life.

Read more

The purpose of this work is to supply children with early development of IgE associated eczema and food allergy with omega-3 LCPUFA before the age of 12 months and assess the effect of the supplementation on the future development of skin symptoms, food allergy, sensitisation against inhalant allergens and asthma in these children. We will also assess immunological markers of Th2-skewed immunity in relation to clinical effect of the supplementation.

Families with children younger than 12 months referred to the paediatric department at Linköping University Hospital, Motala, Norrköping and Jönköping Hospitals in the South East of Sweden, with the diagnosis IgE associated eczema and sensitised against food allergens (egg, milk, wheat and/or soya) will be invited to participate in this study. Clinical examination by a paediatrician and assessment of disease severity with SCORAD will be performed by a research nurse at inclusion. The children will be assessed every six months by a nurse until 2.5 years of age and by a paediatrician at 3 years of age. Later clinical assessment will be performed yearly until age 7.

Being tested
Omega-3 LCPUFA
Keywords
food allergy, eczema, sensitisation, omega-3 long chain polyunsaturated fatty acids, prevention, asthma
Medical subject headings
Food Hypersensitivity, Eczema, Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega-3 LCPUFADietary supplement

    Dosage is 5 ml daily until age 3 years.

Study groups in NCT01473823
Study groupRoleWhat they receive
Placebo oilPlacebo comparatorCanola oil with high oleic acid content flavored with lemon supplied as 5 ml daily.
Receives: Dietary Supplement: Omega-3 LCPUFA
Omega-3 LCPUFAActive comparatorThe omega-3 LCPUFA supplementation comprises of 5 ml daily of "Möller's Tran" flavored with lemon. This dose provides the child with 1200 mg of omega-3 fatty acid of which 600 mg is DHA and 400 mg is EPA.
Receives: Dietary Supplement: Omega-3 LCPUFA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of bronchial asthma

    Measured: 7 years

Secondary outcomes (1)
  1. Severity of allergic symptoms and sensitisations to inhalants

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01473823
Sponsor's protocol ID
OT-013
Acronym
Omega-Treat
Status last verified
Mar 2012
First submitted
9 Nov 2011
Last updated
5 Mar 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Omega-3 LCPUFA in people with Food Allergy and Eczema, run by Ostergotland County Council, Sweden 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Mar 2012. 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?

Results are not available in the source record.

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?

Prevalence of bronchial asthma (time frame: 7 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 5 Mar 2012.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in