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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)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Karel Duchén, MD, Ostergotland County Council, Sweden
ClinicalTrials.gov Identifier:
NCT01473823
First received: November 9, 2011
Last updated: March 2, 2012
Last verified: March 2012

November 9, 2011
March 2, 2012
January 2012
December 2016   (final data collection date for primary outcome measure)
Prevalence of bronchial asthma [ Time Frame: 7 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01473823 on ClinicalTrials.gov Archive Site
Severity of allergic symptoms and sensitisations to inhalants [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treatment of IgE Associated Eczema With Omega-3 Long Chain Polyunsaturated Fatty Acids in Infancy and the Development of Bronchial Asthma in Childhood
Treatment of IgE Associated Eczema With Omega-3 Long Chain Polyunsaturated Fatty Acids in Infancy and the Development of Bronchial Asthma in Childhood

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Food Allergy
  • Eczema
  • Sensitisation
Dietary Supplement: Omega-3 LCPUFA
Dosage is 5 ml daily until age 3 years.
  • Placebo Comparator: Placebo oil
    Canola oil with high oleic acid content flavored with lemon supplied as 5 ml daily.
    Intervention: Dietary Supplement: Omega-3 LCPUFA
  • 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.
    Intervention: Dietary Supplement: Omega-3 LCPUFA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
160
December 2020
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Eczema and sensitisation to food allergens

Exclusion Criteria:

  • Fish allergy within family
Both
3 Months to 12 Months
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01473823
OT-013
No
Karel Duchén, MD, Ostergotland County Council, Sweden
Ostergotland County Council, Sweden
Not Provided
Principal Investigator: Karel Duchén, MD, PhD Ostergotland CC
Ostergotland County Council, Sweden
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP