Predicting the effect of maternal docosahexaenoic acid (DHA) supplementation to reduce early preterm birth in Australia and the United States using results of within country randomized controlled trials

L N Yelland; B J Gajewski; J Colombo; R A Gibson; M Makrides; S E Carlson

doi:10.1016/j.plefa.2016.08.007

Predicting the effect of maternal docosahexaenoic acid (DHA) supplementation to reduce early preterm birth in Australia and the United States using results of within country randomized controlled trials

Prostaglandins Leukot Essent Fatty Acids. 2016 Sep:112:44-9. doi: 10.1016/j.plefa.2016.08.007. Epub 2016 Aug 17.

Authors

L N Yelland¹, B J Gajewski², J Colombo³, R A Gibson⁴, M Makrides⁵, S E Carlson⁶

Affiliations

¹ Healthy Mothers, Babies and Children, South Australian Health and Medical Research Institute, University of Adelaide, South Australia 5005, Australia; The Discipline of Public Health, University of Adelaide, South Australia 5005, Australia.
² The Department of Biostatistics, University of Kansas Medical Center, Kansas City, KS, USA.
³ The Department of Psychology and Schiefelbusch Institute for Life Span Studies, University of Kansas, Lawrence, KS, USA.
⁴ Healthy Mothers, Babies and Children, South Australian Health and Medical Research Institute, University of Adelaide, South Australia 5005, Australia; The School of Agriculture, Food and Wine, University of Adelaide, South Australia 5005, Australia.
⁵ Healthy Mothers, Babies and Children, South Australian Health and Medical Research Institute, University of Adelaide, South Australia 5005, Australia; The Discipline of Pediatrics, University of Adelaide, South Australia 5005, Australia.
⁶ The Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: scarlson@kumc.edu.

Abstract

The DHA to Optimize Mother Infant Outcome (DOMInO) and Kansas DHA Outcomes Study (KUDOS) were randomized controlled trials that supplemented mothers with 800 and 600mg DHA/day, respectively, or a placebo during pregnancy. DOMInO was conducted in Australia and KUDOS in the United States. Both trials found an unanticipated and statistically significant reduction in early preterm birth (ePTB; i.e., birth before 34 weeks gestation). However, in each trial, the number of ePTBs were small. We used a novel Bayesian approach to estimate statistically derived low, moderate or high risk for ePTB, and to test for differences between the DHA and placebo groups. In both trials, the model predicted DHA would significantly reduce the expected proportion of deliveries in the high risk group under the trial conditions of the parent studies. Among the next 300,000 births in Australia we estimated that 1112 ePTB (95% credible interval 51-2189) could be avoided by providing DHA. And in the USA we estimated that 106,030 ePTB (95% credible interval 6400 to 175,700) could be avoided with DHA.

Trial registration: ClinicalTrials.gov NCT00266825.

Keywords: Docosahexaenoic acid; Early preterm birth; Pregnancy; Randomized controlled trials.

Publication types

Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Australia / epidemiology
Bayes Theorem
Dietary Supplements
Docosahexaenoic Acids / administration & dosage*
Double-Blind Method
Female
Gestational Age
Humans
Multicenter Studies as Topic
Pregnancy
Premature Birth / epidemiology*
Premature Birth / prevention & control*
Randomized Controlled Trials as Topic
Treatment Outcome
United States / epidemiology

Substances

Docosahexaenoic Acids

Associated data

ANZCTR/ACTRN12605000569606
ClinicalTrials.gov/NCT00266825

Grants and funding

R01 HD047315/HD/NICHD NIH HHS/United States