Funded in part by DSM, DSM Nutritional Products
Higher dose docosahexaenoic acid supplementation during pregnancy and early preterm birth: A randomised, double-blind, adaptive-design superiority trial
Carlson SE, Gajewski BJ, Valentine CJ, Kerling EH, Weiner CP, Cackovic M, Buhimschi CS, Rogers LK, Sands SA, Brown AR, Mudaranthakam DP, Crawford SA, DeFranco EA
EClinicalMedicine · 73 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (classified by our AI screen)
- Studied in
- People
- Main outcome
- Clinical events such as disease or death
Who paid for it
- Funding
- Industry funded
- University or hospital
- University of Cincinnati
- Government
- Diagnostic Services Manitoba
- Company
- DSM
- Government
- National Institutes of Health
- Company
- DSM Nutritional Products
- Government
- Eunice Kennedy Shriver National Institute of Child Health and Human Development
- Government
- NICHD NIH HHS
- Grants
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01 HD083292); Diagnostic Services Manitoba (R01HD083292); DSM (2646554); DSM (15/991,735)
Based on 7 listed funder(s) and full-text disclosure statement.
Publication
- Published
- 2021-05-17 · EClinicalMedicine · vol. 36 · p. 100905
- Publisher
- Elsevier BV
- Cited
- 96 citations · more than 98% of similar papers · 7.0× the field average
- Impact
- Top 10% most cited in its field
- References
- 36 works
- Access
- Open access (journal) · CC-BY
- Research areas
- Fatty Acid Research and Health · Infant Nutrition and Health · Neonatal Respiratory Health Research
- Keywords
- Medicine, Docosahexaenoic acid, Pregnancy, Gestation, Randomization, Randomized controlled trial, Obstetrics, Live birth, Clinical endpoint, Gestational age, Pediatrics, Internal medicine, Fatty acid, Polyunsaturated fatty acid
13 authors
From US
- Susan E. Carlson · correspondingUniversity of Kansas Medical Center
- Byron J. GajewskiUniversity of Kansas Medical Center
- Christina Jensen ValentineUniversity of Cincinnati
- Elizabeth H. KerlingUniversity of Kansas Medical Center
- Carl P. WeinerUniversity of Kansas Medical Center
- Michael CackovicThe Ohio State University
Abstract
Background
Several meta analyses have concluded n-3 fatty acids, including docosahexaenoic acid (DHA), reduce early preterm birth (EPB, < 34 weeks), however, the amount of DHA required is unclear. We hypothesized that 1000 mg DHA per day would be superior to 200 mg, the amount in most prenatal supplements.
Methods
This randomised, multicentre, double-blind, adaptive-design, superiority trial was conducted in three USA medical centres. Women with singleton pregnancies and 12 to 20 weeks gestation were eligible. randomization was generated in SAS® by site in blocks of 4. The planned adaptive design periodically generated allocation ratios favoring the better performing dose. Managing study personnel were blind to treatment until 30 days after the last birth. The primary outcome was EPB by dose and by enrolment DHA status (low/high). Bayesian posterior probabilities (pp) were determined for planned efficacy and safety outcomes using intention-to-treat. The study is registered with ClinicalTrials.gov (NCT02626299) and closed to enrolment.
Findings
Eleven hundred participants (1000 mg, n = 576; 200 mg, n = 524) were enrolled between June 8, 2016 and March 13, 2020 with the last birth September 5, 2020. 1032 (n = 540 and n = 492) were included in the primary analyses. The higher dose had a lower EPB rate [1.7% (9/540) vs 2.4% (12/492), pp=0.81] especially if participants had low DHA status at enrolment [2.0% (5/249) vs 4.1%, (9/219), pp=0.93]. Participants with high enrolment DHA status did not realize a dose effect [1000 mg: 1.4% (4/289); 200 mg: 1.1% (3/271), pp = 0.57]. The higher dose was associated with fewer serious adverse events (maternal: chorioamnionitis, premature rupture of membranes and pyelonephritis; neonatal: feeding, genitourinary and neurologic problems, all pp>0.90).
Interpretation
Clinicians could consider prescribing 1000 mg DHA daily during pregnancy to reduce EPB in women with low DHA status if they are able to screen for DHA.
Funding
The National Institutes of Health Child Health and Human Development (NICHD) funded the study. Life's DHA™-S oil, DSM Nutritional Products LLC, Switzerland provided all capsules.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).
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