Six year follow up of children at high hereditary risk of allergy born to mothers participating in the DOMInO Trial.
Phase 4
Completed
- Conditions
- Atopy & Allergic DiseaseInflammatory and Immune System - AllergiesAlternative and Complementary Medicine - Other alternative and complementary medicineInflammatory and Immune System - Normal development and function of the immune system
- Registration Number
- ACTRN12615000498594
- Lead Sponsor
- Women's & Children's Health Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 668
Inclusion Criteria
Child was consented to nested 1 and 3 year allergy cohort of the DOMInO trial prior to birth with family history of medically diagnosed allergic disease (eczema, asthma, allergic rhinitis):
Women in DOMInO trial had singleton pregnancy less than 18-21 weeks gestation with no known fetal abnormality: mothers not to have had documented history of alcohol or drug abuse: no participation in other clinical trials with fatty acid
Exclusion Criteria
Maternal bleeding disorders where DHA tuna oil is contraindicated
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of allergic disease symptoms (eczema, allergic rhinitis or wheeze) with sensitisation (determined by a positive skin prick test to food allergens or aeroallergens) in the child.[Six years of age]
- Secondary Outcome Measures
Name Time Method Symptoms of individual allergic disease (eczema, allergic rhinitis or wheeze) with or without sensitisation in the child at 6 years of age. Sensitisation to individual allergen extracts.[Six years of age]