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The Infant Fish Oil Supplementation Study (IFOS): design and research protocol of a double-blind, randomised
S J Meldrum1, N D'Vaz, J Dunstan
1School of Paediatrics and Child Health, University of Western Australia, Perth, WA, Australia. smeldrum@meddent.uwa.edu.au
Insights
This randomized controlled trial investigates if fish oil supplementation in infants reduces allergy incidence and improves neurodevelopment. The study tracks allergy outcomes and infant development up to 60 months.
Area of Science:
- Pediatrics
- Immunology
- Nutritional Science
Background:
- Infant allergies and neurodevelopmental outcomes are significant public health concerns.
- Omega-3 fatty acids, particularly docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), play crucial roles in infant development and immune function.
- Early life supplementation may offer a preventative strategy for allergic diseases and support optimal neurodevelopment.
Purpose of the Study:
- To determine if daily fish oil supplementation (containing DHA and EPA) from birth to 6 months reduces the incidence of allergic disease in high-risk infants.
- To evaluate the effect of fish oil supplementation on infant neurodevelopmental outcomes, including cognitive and language development.
- To assess the impact of the intervention on infant immune status and fatty acid profiles.
Main Methods:
- A double-blind, randomized controlled trial involving infants at high risk for allergic disease.
- Intervention group received 650 mg of fish oil daily, while the placebo group received olive oil, from birth to 6 months.
- Allergy outcomes assessed via clinical history, assessments, and skin prick tests at 12, 30, and 60 months. Neurodevelopmental and language assessments conducted at various intervals up to 30 months.
Main Results:
- Allergy outcomes, including clinical history, assessments, and skin prick tests, were systematically collected.
- Neurodevelopmental assessments and language questionnaires provided data on cognitive and linguistic development.
- Immunological assessments and fatty acid composition analysis in erythrocytes and plasma were performed to understand intervention effects.
Conclusions:
- The study explores a potentially low-cost, non-invasive approach to mitigate allergic disease in early childhood.
- Findings aim to provide clinically relevant insights into the benefits of omega-3 fatty acid supplementation for infant health.
- The research contributes to understanding the role of early nutrition in shaping long-term allergic and developmental trajectories.
Study Design:
The Infant Fish Oil Supplementation Study is a double-blind randomised controlled trial investigating whether the incidence of allergic disease can be reduced and developmental outcomes enhanced through supplementation with omega-3 fatty acids. Infants at high risk of developing allergic disease will be randomised to receive either fish oil or olive oil supplements until 6 months of age and followed up at six postnatal clinic visits to assess allergy outcomes and infant neurodevelopment.
Intervention:
Study groups to consist of a treatment group allocated to receive 650 mg of fish oil daily (250-280 mg docosahexaenoic acid and at least 60 mg eicosapentaenoic acid and a placebo group (olive oil) from birth to 6 months of age.
Outcomes:
Allergy outcomes will be assessed by clinical history, clinical assessments and allergen skin prick tests at the 12, 30 and 60 month visits. Neurodevelopmental assessments to be conducted at 18 months, and language questionnaires at 12, 18 and 30 months. Samples will be collected from mothers antenatally, from infants at birth, and at clinic visits from 6 months onwards for immunological assessments. Fatty acid composition to be measured in erythrocytes and plasma (at birth and after the supplementation period) to assess the effect of the intervention on fatty acid status. Information on medical history, diet and other lifestyle factors at an antenatal clinic visit and postnatal clinic visits will also be collected.
Conclusion:
This study is designed to examine clinically relevant effects of a novel, non-invasive and potentially low cost approach to reduce the incidence of allergic disease and facilitate neurodevelopment during early childhood.
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