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
  Purpose

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 Intervention
Food Allergy
Eczema
Sensitisation
Dietary Supplement: Omega-3 LCPUFA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Ostergotland County Council, Sweden:

Primary Outcome Measures:
  • Prevalence of bronchial asthma [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of allergic symptoms and sensitisations to inhalants [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: January 2012
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   3 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eczema and sensitisation to food allergens

Exclusion Criteria:

  • Fish allergy within family
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473823

Locations
Sweden
Allergicentrum
Linköping, Sweden
Sponsors and Collaborators
Ostergotland County Council, Sweden
Investigators
Principal Investigator: Karel Duchén, MD, PhD Ostergotland CC
  More Information

No publications provided

Responsible Party: Karel Duchén, MD, Principal Investigator, Ostergotland County Council, Sweden
ClinicalTrials.gov Identifier: NCT01473823     History of Changes
Other Study ID Numbers: OT-013
Study First Received: November 9, 2011
Last Updated: March 2, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Ostergotland County Council, Sweden:
food allergy
eczema
sensitisation
omega-3 long chain polyunsaturated fatty acids
prevention
asthma

Additional relevant MeSH terms:
Food Hypersensitivity
Eczema
Asthma
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 18, 2014