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https://hdl.handle.net/2440/139739
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Type: | Journal article |
Title: | Predictors of compliance with higher dose omega-3 fatty acid supplementation during pregnancy and implications for the risk of prematurity: exploratory analysis of the ORIP randomised trial |
Author: | Sullivan, T.R. Yelland, L.N. Gibson, R.A. Thakkar, S.K. Huang, F. Best, K.P. Devaraj, S. Zolezzi, I.S. Makrides, M. |
Citation: | BMJ Open, 2023; 13(9):e076507-1-e076507-8 |
Publisher: | BMJ Journals |
Issue Date: | 2023 |
ISSN: | 2044-6055 2044-6055 |
Statement of Responsibility: | Thomas R Sullivan, Lisa N Yelland, Robert A Gibson, Sagar K Thakkar, Fang Huang, Karen P Best, Surabhi Devaraj, Irma Silva Zolezzi, Maria Makrides |
Abstract: | Background: Intention-to-treat analyses of the Omega‐3 to Reduce the Incidence of Prematurity (ORIP) trial found that omega-3 (n-3) fatty acid supplementation reduces the risk of prematurity in the subgroup of women with a singleton pregnancy and low n-3 status early in pregnancy, but not overall. However, results may have been influenced by less-than-optimal compliance. Objectives: To identify predictors of compliance with n-3 supplementation and determine treatment effects among compliers. Design: Exploratory analyses of a multicentre-blinded randomised trial. Setting: 6 tertiary care centres in Australia. Participants: 5328 singleton pregnancies. Interventions: Daily capsules containing 900 mg n-3 long-chain polyunsaturated fatty acids or vegetable oil, consumed from before 20 weeks gestation until 34 weeks gestation. Outcome measures: Early preterm (<34 weeks gestation) and preterm birth (<37 weeks gestation). Women were considered compliant if they reported missing less than a third of their allocated capsules in the previous week during a mid-pregnancy appointment. Results: Among 2654 singleton pregnancies in the n-3 intervention group, 1727 (65%) were deemed compliant with supplementation. Maternal characteristics associated with compliance included age, years of full-time education, consuming alcohol but not smoking in the 3 months leading up to pregnancy, fewer previous births and taking dietary supplements at enrolment. Based on complier average causal effects, n-3 supplementation reduced the risk of preterm birth in compliers (relative risk=0.76; 95% CI 0.60 to 0.97), but not early preterm birth (relative risk=0.80; 95% CI 0.44 to 1.46). Consistent with intention-to-treat analyses, the lack of an overall effect on early preterm birth in compliers appeared to be due to beneficial effects in women with low n-3 status at enrolment but not women with replete status. Conclusions: Results in compliers were similar to those from intention-to-treat analyses, suggesting that non-compliance was not a major factor in explaining outcomes from the ORIP trial. Trial registration number: ACTRN12613001142729. |
Keywords: | Humans Premature Birth Fatty Acids, Omega-3 Fatty Acids Capsules Pregnancy Dietary Supplements Infant, Newborn Australia Female |
Rights: | © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. |
DOI: | 10.1136/bmjopen-2023-076507 |
Grant ID: | http://purl.org/au-research/grants/nhmrc/1135155 |
Published version: | http://dx.doi.org/10.1136/bmjopen-2023-076507 |
Appears in Collections: | Agriculture, Food and Wine publications Medicine publications Public Health publications |
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