Evidence map›Paper›PMID 36680919›Full record

Trial reportClinical nutrition (Edinburgh, Scotland)2023

Early and late preterm birth rates in participants adherent to randomly assigned high dose docosahexaenoic acid (DHA) supplementation in pregnancy.

S E Carlson, B J Gajewski, C J Valentine, S A Sands, A R Brown, E H Kerling, S A Crawford, C S Buhimschi, C P Weiner, M Cackovic and 3 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical nutrition (Edinburgh, Scotland), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02626299 (Assessment of DHA On Reducing Early Preterm Birth), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.3field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02626299 phase3completednot on this map

Assessment of DHA On Reducing Early Preterm Birth (ADORE Trial)

TypeinterventionalSponsorUniversity of Kansas Medical CenterRan2016 to 2020Enrolled1,100ConditionsPreterm BirthArmsDocosahexaenoic acid - 800mg/day, Docosahexaenoic acid - 200mg/day, Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 14 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 1 country.

S E CarlsonUniversity of Kansas Medical Center, Department of Dietetics and Nutrition, Kansas City, KS, USA. Electronic address: scarlson@kumc.edu.
B J GajewskiUniversity of Kansas Medical Center, Department of Biostatistics & Data Science, Kansas City, KS, USA.
C J ValentineUniversity of Arizona, Department of Pediatrics, Tucson, AZ, USA.
S A SandsUniversity of Kansas Medical Center, Department of Dietetics and Nutrition, Kansas City, KS, USA.
A R BrownUniversity of Kansas Medical Center, Department of Biostatistics & Data Science, Kansas City, KS, USA.
E H KerlingUniversity of Kansas Medical Center, Department of Dietetics and Nutrition, Kansas City, KS, USA.
S A CrawfordUniversity of Kansas Medical Center, Department of Dietetics and Nutrition, Kansas City, KS, USA.
C S BuhimschiUniversity of Illinois, Department of Obstetrics and Gynecology, Chicago, IL, USA.
C P WeinerCreighton University Medical School, Obstetrics and Gynecology, Department of Obstetrics and Gynecology, Phoenix, AZ, USA.
M CackovicOhio State University, Department of Obstetrics and Gynecology, Columbus, OH, USA.
E A DeFrancoUniversity of Cincinnati, Department of Obstetrics and Gynecology, Cincinnati, OH, USA.
D P MudaranthakamUniversity of Arizona, Department of Pediatrics, Tucson, AZ, USA.
L K RogersNationwide Children's Hospital, Columbus, OH, USA.
University of Kansas Medical Center · USUniversity of Arizona · USCreighton University · USNationwide Children's Hospital · USThe Ohio State University · USUniversity of Cincinnati · USUniversity of Illinois Chicago · US

Funding

Identification of dietary supplement practices and nutrient intake among a diverse US cohort of pregnant womenR01HD083292 · NICHD · UNIVERSITY OF KANSAS MEDICAL CENTER · PI CARLSON, SUSAN E, GAJEWSKI, BYRON J. · 2016 to 2020
$3.3M
NICHD NIH HHS R01 HD083292
6 · The paper itself

Abstract

backgroundIntention-to-treat analyses do not address adherence. Per protocol analyses treat nonadherence as a protocol deviation and assess if the intervention is effective if followed.

objectiveTo determine the rate of early preterm birth (EPTB, <34 weeks gestation) and preterm birth (PTB, <37 weeks gestation) in participants who adhered to a randomly assigned docosahexaenoic acid (DHA) dose of 1000 mg/day. STUDY

designEleven hundred women with a singleton pregnancy were enrolled before 20-weeks' gestation, provided a capsule with 200 mg/day DHA and randomly assigned to two additional capsules containing a placebo or 800 mg of DHA. In the Bayesian Adaptive Design, new randomization schedules were determined at prespecified intervals. In each randomization, the group with the most EPTB was assigned fewer participants than the other group. Adherence was defined a priori as a postpartum red blood cell phospholipid DHA (RBC-PL-DHA) ≥5.5%.and post hoc as ≥8.0% RBC-PL-DHA, the latter after examination of postpartum RBC-PL-DHA. Bayesian mixture models were fitted for gestational age and dichotomized for EPTB and PTB as a function of baseline RBC-PL-DHA and dose-adherence. Bayesian hierarchical models were also fitted for EPTB by dose adherence and quartiles of baseline RBC-PL-DHA.

resultsAdherence to the high dose using both RBC-PL-DHA cut points resulted in less EPTB compared to 200 mg [Bayesian posterior probability (pp) = 0.93 and 0.92, respectively]. For participants in the two lowest quartiles of baseline DHA status, adherence to the higher dose resulted in lower EPTB (≥5.5% RBC-PL-DHA, quartiles 1 and 2, pp = 0.95 and 0.96; ≥8% RBC-PL-DHA, quartiles 1 and 2, pp = 0.94 and 0.95). Using the Bayesian model, EPTB was reduced by 65%, from 3.45% to 1.2%, using both cut points. Adherence also reduced PTB before 35, 36 and 37 weeks using both cut points (pp ≥ 0.95). In general, performance of the nonadherent subgroup mirrored that of participants assigned to 200 mg.

conclusionAdherence to high dose DHA reduced EPTB and PTB. The largest effect of adherence on reducing EPTB was observed in women with low baseline DHA levels. CLINICALTRIALS: gov (NCT02626299).

Indexed as

Premature BirthBayes TheoremDietary SupplementsDocosahexaenoic AcidsFemaleGestational AgeHumansInfant, NewbornPregnancyDocosahexaenoic AcidsClinical trial adherenceDHAPregnancyPreterm birthRed blood cell phospholipid DHA

Identifiers

PMID36680919
PMCPMC10546372
OpenAlexW4315643799

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.