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)
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| ClinicalTrials.gov Identifier: NCT01473823 |
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Recruitment Status :
Enrolling by invitation
First Posted : November 17, 2011
Last Update Posted : March 5, 2012
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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 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 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo oil
Canola oil with high oleic acid content flavored with lemon supplied as 5 ml daily.
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Dietary Supplement: Omega-3 LCPUFA
Dosage is 5 ml daily until age 3 years. |
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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.
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Dietary Supplement: Omega-3 LCPUFA
Dosage is 5 ml daily until age 3 years. |
- Prevalence of bronchial asthma [ Time Frame: 7 years ]
- Severity of allergic symptoms and sensitisations to inhalants [ Time Frame: 3 years ]
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| Ages Eligible for Study: | 3 Months to 12 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Eczema and sensitisation to food allergens
Exclusion Criteria:
- Fish allergy within family
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01473823
| Sweden | |
| Allergicentrum | |
| Linköping, Sweden | |
| Principal Investigator: | Karel Duchén, MD, PhD | Ostergotland CC |
| 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 Key Record Dates |
| Last Update Posted: | March 5, 2012 |
| Last Verified: | March 2012 |
Keywords provided by Karel Duchén, MD, Ostergotland County Council, Sweden:
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food allergy eczema sensitisation |
omega-3 long chain polyunsaturated fatty acids prevention asthma |
Additional relevant MeSH terms:
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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 |