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)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Food Allergy; Eczema; Sensitisation	Dietary Supplement: Omega-3 LCPUFA	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	160 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
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 Start Date :	January 2012
Estimated Primary Completion Date :	December 2016
Estimated Study Completion Date :	December 2020

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Placebo Comparator: Placebo oil; Canola oil with high oleic acid content flavored with lemon supplied as 5 ml daily.	Dietary Supplement: Omega-3 LCPUFA; Dosage is 5 ml daily until age 3 years.
Active Comparator: Omega-3 LCPUFA; 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.	Dietary Supplement: Omega-3 LCPUFA; Dosage is 5 ml daily until age 3 years.

Outcome Measures

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Primary Outcome Measures :

1. Prevalence of bronchial asthma [ Time Frame: 7 years ]

Secondary Outcome Measures :

1. Severity of allergic symptoms and sensitisations to inhalants [ Time Frame: 3 years ]

Eligibility Criteria

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Ages Eligible for Study:	3 Months to 12 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Eczema and sensitisation to food allergens

Exclusion Criteria:

• Fish allergy within family

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Sweden
Allergicentrum
Linköping, Sweden

Sponsors and Collaborators

Ostergotland County Council, Sweden

Investigators

Principal Investigator:	Karel Duchén, MD, PhD	Ostergotland CC

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Karel Duchén, MD, Principal Investigator, Ostergotland County Council, Sweden
ClinicalTrials.gov Identifier:	NCT01473823 History of Changes
Other Study ID Numbers:	OT-013
First Posted:	November 17, 2011
Last Update Posted:	March 5, 2012
Last Verified:	March 2012

Keywords provided by Karel Duchén, MD, Ostergotland County Council, Sweden:

food allergy; eczema; sensitisation	omega-3 long chain polyunsaturated fatty acids; prevention; asthma

Additional relevant MeSH terms:

Eczema; Food Hypersensitivity; Asthma; Dermatitis; Skin Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate	Hypersensitivity; Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity