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Efficacy and safety of long-chain polyunsaturated fatty acid supplementation of infant-formula milk: a randomised trial
Citation
Lucas, A and Stafford, M and Morley, R and Abbott, R and Stephenson, T and MacFadyen, U and Elias-Jones, A and Clements, H, Efficacy and safety of long-chain polyunsaturated fatty acid supplementation of infant-formula milk: a randomised trial, Lancet, 354, (9194) pp. 1948-1954. ISSN 0140-6736 (1999) [Refereed Article]
DOI: doi:10.1016/S0140-6736(99)02314-4
Abstract
Background. We tested whether addition of n-3 and n-6 long-chain polyunsaturated fatty acids (LCPUFA) to infant-formula milk during the first 6 months promotes long-term cognitive and motor development, without adverse consequences. Methods. We did a double-blind, randomised, controlled, efficacy and safety trial of formula with and without LCPUFAs, with an additional breastfed reference group, in four hospitals in two cities in the UK. The participants were 447 healthy full-term babies. 309 were fed formula (155 without LCPUFAs) and 138 were breastfed for at least 6 weeks. The main outcome measures were: Bayley Mental and Psychomotor Development Indices (MDI, PDI) at 18 months (primary efficacy outcome) and Knobloch, Passamanick, and Sherrards test at 9 months (secondary outcome). Principal safety outcomes were: infection, atopy, growth, and gastrointestinal tolerance. Findings. Babies fed formula with and without LCPUFA did not differ in cognitive or motor development, growth, infection, atopy or tolerance. The mean (95% CI) MDI was 0.5 (-2.7 to 3.8) units and the PDI 0.6 (-1.8 to 3.0) units higher in the supplementation group. Formula-fed infants had similar developmental scores to the breastfed reference group after adjustment for higher social class and maternal education in the latter. Interpretation. There was no evidence of a beneficial or adverse effect on cognitive and motor development or growth up to 18 months. Although no significant differences in safety outcomes were observed, we suggest such data should be collected in future LCPUFA trials. Our trial does not provide support for addition of LCPUFA to standard infant formula but we are now doing further follow-up of this cohort.
Item Details
| Item Type: | Refereed Article |
|---|---|
| Research Division: | Health Sciences |
| Research Group: | Epidemiology |
| Research Field: | Epidemiology not elsewhere classified |
| Objective Division: | Health |
| Objective Group: | Specific population health (excl. Indigenous health) |
| Objective Field: | Neonatal and child health |
| UTAS Author: | Morley, R (Dr Ruth Morley) |
| ID Code: | 17801 |
| Year Published: | 1999 |
| Web of Science® Times Cited: | 164 |
| Deposited By: | Menzies Centre |
| Deposited On: | 1999-08-01 |
| Last Modified: | 2011-11-30 |
| Downloads: | 0 |
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