The Infant Fish Oil Supplementation Study (IFOS): Design and research protocol of a double-blind, randomised controlled n-3 LCPUFA intervention trial in term infants

Contemporary Clinical Trials

Volumn 32, Issue 5, 2011, Pages 771-778

  Meldrum, S J ^a,c   D'Vaz, N ^a   Dunstan, J ^a   Mori, T A ^b   Prescott, S L ^a  

^a UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^b UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^c PRINCESS MARGARET HOSPITAL FOR CHILDREN   (Australia)

Author keywords

Allergy prevention; Fish oil; Neurodevelopment; Randomised controlled trial; Supplementation

Indexed keywords

DOCOSAHEXAENOIC ACID; FISH OIL; ICOSAPENTAENOIC ACID; LONG CHAIN FATTY ACID; OLIVE OIL; PLACEBO; POLYUNSATURATED FATTY ACID;

ALLERGY; ARTICLE; CHILD DEVELOPMENT; CLINICAL PROTOCOL; CLINICAL RESEARCH; DIET SUPPLEMENTATION; DOUBLE BLIND PROCEDURE; HUMAN; INFANT; INFANT NUTRITION; MAJOR CLINICAL STUDY; NERVOUS SYSTEM DEVELOPMENT; OUTCOME ASSESSMENT; PRICK TEST; RANDOMIZED CONTROLLED TRIAL (TOPIC); SKIN TEST;

CLINICAL PROTOCOLS; DIETARY SUPPLEMENTS; DOCOSAHEXAENOIC ACIDS; DOUBLE-BLIND METHOD; EICOSAPENTAENOIC ACID; FATTY ACIDS, OMEGA-3; FATTY ACIDS, UNSATURATED; FEMALE; FISH OILS; HUMANS; HYPERSENSITIVITY; INFANT; INFANT WELFARE; INFANT, NEWBORN; MALE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 79960889446     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2011.05.019     Document Type: Article

References (34)

1. Beasley R. Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema: ISAAC. Lancet 1998, 351(9111):1225-1232.
2. Black P., Sharpe S. Dietary fat and asthma: is there a connection?. Eur Respir J 1997, 10(1):6-12.
3. Calder P.C. Polyunsaturated fatty acids and inflammatory processes: new twists in an old tale. Biochimie 2009, 91(6):791-795.
4. Prescott S.L., Calder P.C. N-3 polyunsaturated fatty acids and allergic disease. Curr Opin Clin Nutr Metab Care 2004, 7(2):123-129.
5. Jung U.T., Tighe T.C., Deckelbaum R.J. n-3 fatty acids and cardiovascular disease: mechanisms underlying beneficial effects. Am J Clin Nutr 2008, 87(6):2003-2008.
6. Proudman S.M., James M.J. Dietary omega-3 fats for treatment of inflammatory joint disease: efficacy and utility. Rheum Dis Clin North Am 2008, 34(2):469-479.
7. Calder P. n-3 polyunsaturated fatty acids and inflammation: from molecular biology to the clinic. Lipids 2003, 38(4):343-352.
8. Calder P.C. Polyunsaturated fatty acids, inflammatory processes and inflammatory bowel diseases. Mol Nutr Food Res 2008, 52(8):885-897.
9. Woods R.K., Abramson M.J. Dietary marine fatty acids (fish oil) for asthma in adults and children. Cochrane Database Syst Rev 2002, 3. (CD001283).
10. Calvani M., Alessandri C., Sopo S.M., Panetta V., Pingitore G., Tripodi S., et al. Consumption of fish, butter and margarine during pregnancy and development of allergic sensitizations in the offspring: role of maternal atopy. Pediatr Allergy Immunol 2006, 17(2):94-102.
11. Newson R.B., Henderson A.J., Emmett P.M., Sherriff A., Calder P.C. Umbilical cord and maternal red blood cell fatty acids and early childhodd wheezing and eczema. J Allergy Clin Immunol 2004, 114(3):531-537.
12. Krauss-Etschmann S., Shadid R., Campoy C., Hoster E., Demmelmair H., Jimenez M., et al. Effects of fish-oil and folate supplementation of pregnant women on maternal and fetal plasma concentrations of docosahexaenoic acid and eicosapentaenoic acid: a European randomized multicenter trial. Am J Clin Nutr 2007, 85(5):1392-1400.
13. Prescott S.L., et al. Maternal fish oil supplementation in pregnancy modifies neonatal leukotriene production by cord-blood-derived neutrophils. Clin Sci (Lond) 2007, 113(10):409-416.
14. Dunstan J.A., Mori T.A., Barden A., Beilin L.J., Taylor A.L., Holt P.G., et al. Fish oil supplementation in pregnancy modifies neonatal allergen-specific immune responses and clinical outcomes in infants at high risk of atopy: A randomized, controlled trial. J Allergy Clin Immunol 2003, 112(6):1178-1184.
15. Innis S.M. Dietary omega 3 fatty acids and the developing brain. Brain Res 2008, 1237:35-43.
16. Martinez M. Tissue levels of polyunsaturated fatty acids during early human development. J Pediatr 1992, 120:S129-S138.
17. Jensen C.L., Lapillonne A. Docosahexaenoic acid and lactation. Prostaglandins Leukot Essent Fatty Acids 2009, 81:175-178.
18. Hoffman D.R., Boettcher J.A., Diersen-Schade D.A. Toward optimizing vision and cognition in term infants by dietary docosahexaenoic and arachidonic acid supplementation: a review of randomized controlled trials. PLEFA 2009, 81(2-3):151-158.
19. Bayley N. Bayley Scales of Infant and Toddler Development 2006, Harcourt Assessment, San Antonio, TX.
20. Achenbach T.M., Rescola L.A. Manual for the ASEBA Preschool Forms and Profiles 2000, University of Vermont Department of Psychiatry, Burlington, V.T.
21. Fenson L., et al. The MacArthur Communicative Development Inventories: User's guide and technical manual 1993, Singular Publishing Group, San Diego, CA.
22. Dunstan J.A., Roper J., Mitoulas L., Hartmann P.E., Simmer K., Prescott S.L. The effect of supplementation with fish oil during pregnancy on breast milk immunoglobulin A, soluble CD14, cytokine levels and fatty acid composition. Clin Exp Allergy 2004, 34:1237-1242.
23. Litonjua A., Carey V.J., Burge H.A., Weiss S.T., Gold D.R. Parental history and the risk for childhood asthma. Does mother confer more risk than father?. Am J Respir Crit Care Med 1998, 158(1):176-181.
24. Lenth R.V. Some practical guidelines for effective sample size determination. Am Stat 2001, 55(3):187-193.
25. Prescott S., Macaubas C., Holt B., Smallacombe T., Loh R., Sly P., et al. Transplacental priming of the human immune system to environmental allergens: universal skewing of initial T-cell responses towards Th-2 cytokine profile. J Immunol 1998, 160:4730-4737.
26. Yuhas R., Pramuk K., Lien E. Human milk fatty acid composition from nine countries varies most in DHA. Lipids 2006, 41(9):851-858.
27. CSIRO, D.o.H.a.F.S.A. CSIRO Australian food and nutrition surveys 1988 & 1993: results from the CSIRO Australian food and nutrition surveys 1988 and 1993 1996, Adelaide, S.A. D.o.H.N. CSIRO (Ed.).
28. Hanifen J.M., Rajka G. Diagnostic features of atopic dermatitis. Acta Derm Venereol 1980, 92(Supplement 144):44-47.
29. Stalder J.F., Taïeb A. Severity scoring of atopic dermatitis: the SCORAD index. Dermatology 1993, 186(1):23-31.
30. Dunstan J.A., et al. Fish oil supplementation in pregnancy modifies neonatal allergen-specific immune responses and clinical outcomes in infants at high risk of atopy: a randomized, controlled trial. J Allergy Clin Immunol 2003, 112(6):1178-1184.
31. Makrides M., Neumann M.A., Simmer K., Gibson R.A. Erythrocyte fatty acids of term infants fed either breast milk, standard formula or formula supplemented with long-chain polyunsaturates. Lipids 1995, 30:941-948.
32. Lovibond S.H., Lovibond P.F. Manual for the Depression Anxiety Stress Scales (DASS) 1993, University of New South Wales.
33. Olsen S.F., Hansen H.S., Sandstrom B., Jensen B. Erythrocyte levels compared with reported dietary intake of marine n-3 fatty acids in pregnant women. Br J Nutr 1995, 73:387-395.
34. Skeaff C.M., Hodson L., McKenzie J.E. Dietary-induced changes in fatty acid composition of human plasma, platelet, and erythrocyte lipids follow a similar time course. J Nutr 2006, 136:565-569.