Effect of n-3 long chain polyunsaturated fatty acid supplementation in pregnancy on infants’ allergies in first year of life: randomised controlled trial

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D J Palmer, research fellow1,
T Sullivan, statistician2,
M S Gold, consultant paediatric allergist3,
S L Prescott, consultant paediatric allergist4,
R Heddle, clinical immunologist5,
R A Gibson, professor of functional foods6,
M Makrides, professor of human nutrition1 3

¹Women’s and Children’s Health Research Institute, 72 King William Road, North Adelaide, South Australia, 5006, Australia
²Data Management and Analysis Centre, University of Adelaide, Adelaide, South Australia, 5005, Australia
³School of Paediatrics and Reproductive Health, University of Adelaide, North Adelaide, South Australia, 5006
⁴Princess Margaret Hospital for Children, Perth, Western Australia, 6008, Australia
⁵SA Pathology, Royal Adelaide Hospital, Adelaide, South Australia, 5005
⁶School of Agriculture, Food and Wine, University of Adelaide, Glen Osmond, South Australia, 5064, Australia

Correspondence to: M Makrides maria.makrides{at}health.sa.gov.au

Accepted 6 November 2011

Abstract

Objective To determine whether dietary n-3 long chain polyunsaturated fatty acid (LCPUFA) supplementation of pregnant women with a fetus at high risk of allergic disease reduces immunoglobulin E associated eczema or food allergy at 1 year of age.

Design Follow-up of infants at high hereditary risk of allergic disease in the Docosahexaenoic Acid to Optimise Mother Infant Outcome (DOMInO) randomised controlled trial.

Setting Adelaide, South Australia.

Participants 706 infants at high hereditary risk of developing allergic disease whose mothers were participating in the DOMInO trial.

Interventions The intervention group (n=368) was randomly allocated to receive fish oil capsules (providing 900 mg of n-3 LCPUFA daily) from 21 weeks’ gestation until birth; the control group (n=338) received matched vegetable oil capsules without n-3 LCPUFA.

Main outcome measure Immunoglobulin E associated allergic disease (eczema or food allergy with sensitisation) at 1 year of age.

Results No differences were seen in the overall percentage of infants with immunoglobulin E associated allergic disease between the n-3 LCPUFA and control groups (32/368 (9%) v 43/338 (13%); unadjusted relative risk 0.68, 95% confidence interval 0.43 to 1.05, P=0.08; adjusted relative risk 0.70, 0.45 to 1.09, P=0.12), although the percentage of infants diagnosed as having atopic eczema (that is, eczema with associated sensitisation) was lower in the n-3 LCPUFA group (26/368 (7%) v 39/338 (12%); unadjusted relative risk 0.61, 0.38 to 0.98, P=0.04; adjusted relative risk 0.64, 0.40 to 1.02, P=0.06). Fewer infants were sensitised to egg in the n-3 LCPUFA group (34/368 (9%) v 52/338 (15%); unadjusted relative risk 0.61, 0.40 to 0.91, P=0.02; adjusted relative risk 0.62, 0.41 to 0.93, P=0.02), but no difference between groups in immunoglobulin E associated food allergy was seen.

Conclusion n-3 LCPUFA supplementation in pregnancy did not reduce the overall incidence of immunoglobulin E associated allergies in the first year of life, although atopic eczema and egg sensitisation were lower. Longer term follow-up is needed to determine if supplementation has an effect on respiratory allergic diseases and aeroallergen sensitisation in childhood.

Trial registration Australian New Zealand Clinical Trials Registry ACTRN12610000735055 (DOMInO trial: ACTRN12605000569606).

Footnotes

We thank the families who participated and the following investigators and research team members who supported the data collection: A Anderson, E Griffith, S Warcup, F Tan, D Tye, P Quinn, P Di Giovine, M O’Grady, C Oates, A Scott, W Helbers, N Naccarella, H Loudis, and M Crabb. We also acknowledge the support of the Docosahexaenoic Acid to Optimise Mother Infant Outcome (DOMInO) Trial Steering Committee: M Makrides, R A Gibson, A J McPhee, L Yelland, J Quinlivan, and P Ryan.
Contributors: MM, MSG, SLP, and RAG were responsible for the study concept and design. DP, MM, TS, MSG, SLP, and RH were involved in acquisition of data. All authors analysed and interpreted data. DP, MM, and TS drafted the manuscript. All authors revised the manuscript critically for important intellectual content. DP, MM, and TS did the statistical analysis. MM, MSG, SLP, RAG, and DP were involved in obtaining funding. DP, MM, MSG, and RH supervised the study. MM is the guarantor.
Funding: The study was supported by grants from the Australian National Health and Medical Research Council (ID 399389) and Australian Egg Corporation Limited. Treatment and placebo capsules were donated by Efamol, UK.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: all authors had support from the National Health and Medical Research Council (NHMRC) of Australia and the Australian Egg Corporation for the submitted work; MSG has received honorariums from Nutricia; SLP has received grants from the NHMRC and honorariums from the Nestlé Nutrition Institute and Fonterra and has been paid for lectures by the World Allergy Association and the American Academy of Asthma, Allergy and Immunology; RH has been paid for expert testimony from Analysis Plus and Rodika Research Services and has received grants from Commonwealth Serum Laboratories, Vaxine, GlaxoSmithKline, and Healthed; RAG has received grants from the NHMRC and honorariums from Fonterra; MM has received grants from the NHMRC and honorariums from Fonterra, Nestlé Nutrition Institute, and Nutricia.
Ethical approval: Approval was granted by the human research ethics committees of each centre—Women’s and Children’s Hospital, Adelaide (REC 1657) and Flinders Medical Centre, Adelaide (REC 199045).
Data sharing: No additional data available.

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