Treatment of IgE Associated Eczema With Omega-3 Long Chain Polyunsaturated Fatty Acids in Infancy and the Development of Bronchial Asthma in Childhood (Omega-Treat)
Primary Purpose
Food Allergy, Eczema, Sensitisation
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Omega-3 LCPUFA
Sponsored by
About this trial
This is an interventional prevention trial for Food Allergy focused on measuring food allergy, eczema, sensitisation, omega-3 long chain polyunsaturated fatty acids, prevention, asthma
Eligibility Criteria
Inclusion Criteria:
- Eczema and sensitisation to food allergens
Exclusion Criteria:
- Fish allergy within family
Sites / Locations
- Allergicentrum
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo oil
Omega-3 LCPUFA
Arm Description
Canola oil with high oleic acid content flavored with lemon supplied as 5 ml daily.
The 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.
Outcomes
Primary Outcome Measures
Prevalence of bronchial asthma
Secondary Outcome Measures
Severity of allergic symptoms and sensitisations to inhalants
Full Information
NCT ID
NCT01473823
First Posted
November 9, 2011
Last Updated
March 2, 2012
Sponsor
Ostergotland County Council, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT01473823
Brief Title
Treatment of IgE Associated Eczema With Omega-3 Long Chain Polyunsaturated Fatty Acids in Infancy and the Development of Bronchial Asthma in Childhood
Acronym
Omega-Treat
Official Title
Treatment of IgE Associated Eczema With Omega-3 Long Chain Polyunsaturated Fatty Acids in Infancy and the Development of Bronchial Asthma in Childhood
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ostergotland County Council, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy, Eczema, Sensitisation
Keywords
food allergy, eczema, sensitisation, omega-3 long chain polyunsaturated fatty acids, prevention, asthma
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo oil
Arm Type
Placebo Comparator
Arm Description
Canola oil with high oleic acid content flavored with lemon supplied as 5 ml daily.
Arm Title
Omega-3 LCPUFA
Arm Type
Active Comparator
Arm Description
The 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 LCPUFA
Intervention Description
Dosage is 5 ml daily until age 3 years.
Primary Outcome Measure Information:
Title
Prevalence of bronchial asthma
Time Frame
7 years
Secondary Outcome Measure Information:
Title
Severity of allergic symptoms and sensitisations to inhalants
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eczema and sensitisation to food allergens
Exclusion Criteria:
Fish allergy within family
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karel Duchén, MD, PhD
Organizational Affiliation
Ostergotland CC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergicentrum
City
Linköping
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Treatment of IgE Associated Eczema With Omega-3 Long Chain Polyunsaturated Fatty Acids in Infancy and the Development of Bronchial Asthma in Childhood
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