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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01473823
Recruitment Status : Enrolling by invitation
First Posted : November 17, 2011
Last Update Posted : March 5, 2012
Sponsor:
Information provided by (Responsible Party):
Karel Duchén, MD, Ostergotland County Council, Sweden

Tracking Information
First Submitted Date  ICMJE November 9, 2011
First Posted Date  ICMJE November 17, 2011
Last Update Posted Date March 5, 2012
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2011)
Prevalence of bronchial asthma [ Time Frame: 7 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2011)
Severity of allergic symptoms and sensitisations to inhalants [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of IgE Associated Eczema With Omega-3 Long Chain Polyunsaturated Fatty Acids in Infancy and the Development of Bronchial Asthma in Childhood
Official Title  ICMJE Treatment of IgE Associated Eczema With Omega-3 Long Chain Polyunsaturated Fatty Acids in Infancy and the Development of Bronchial Asthma in Childhood
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Food Allergy
  • Eczema
  • Sensitisation
Intervention  ICMJE Dietary Supplement: Omega-3 LCPUFA
Dosage is 5 ml daily until age 3 years.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: November 14, 2011)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Eczema and sensitisation to food allergens

Exclusion Criteria:

  • Fish allergy within family
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 12 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01473823
Other Study ID Numbers  ICMJE OT-013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karel Duchén, MD, Ostergotland County Council, Sweden
Study Sponsor  ICMJE Ostergotland County Council, Sweden
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karel Duchén, MD, PhD Ostergotland CC
PRS Account Ostergotland County Council, Sweden
Verification Date March 2012

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