Higher Dose Docosahexaenoic Acid Supplementation During Pregnancy and Early Preterm Birth: A Randomised, Double-Blind, Adaptive-Design Superiority Trial

2021 ◽  
Author(s):  
Susan E. Carlson ◽  
Byron J. Gajewski ◽  
Christina J. Valentine ◽  
Elizabeth H. Kerling ◽  
Carl P. Weiner ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Docosahexaenoic Acid ◽  
Adaptive Design ◽  
Double Blind ◽  
Acid Supplementation ◽  
Blind Adaptive ◽  
Superiority Trial ◽  
Early Preterm Birth

scholarly journals Higher-Dose DHA Supplementation Modulates Immune Responses in Pregnancy and Is Associated with Decreased Preterm Birth

Nutrients ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 4248
Author(s):  
Christina J. Valentine ◽  
Aiman Q. Khan ◽  
Alexandra R. Brown ◽  
Scott A. Sands ◽  
Emily A. Defranco ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Adaptive Design ◽  
Plasma Concentrations ◽  
Mechanistic Explanation ◽  
Maternal Blood ◽  
Double Blind ◽  
Maternal Immune System ◽  
Superiority Trial ◽  
Secondary Study ◽  
Early Preterm Birth

Pregnancy and parturition involve extensive changes in the maternal immune system. In our randomized, multi-site, double-blind superiority trial using a Bayesian adaptive design, we demonstrated that 1000 mg/day of docosahexaenoic acid (DHA) was superior to 200 mg/day in preventing both early preterm birth (less than 34 weeks’ gestation) and preterm birth (less than 37 weeks’ gestation). The goal of this secondary study is to compare the effects of 1000 mg/day versus 200 mg/day on maternal inflammation, a possible mechanism by which DHA may prevent preterm birth. Maternal blood samples were collected at enrollment (12–20 weeks’ gestation) and at delivery. Red blood cell DHA levels were measured by gas chromatography, and plasma concentrations of sRAGE, IL-6, IL-1β, TNFα, and INFγ were measured by ELISA. Data were analyzed for associations with the DHA dose, gestational age at birth, and preterm birth (<37 weeks). Higher baseline and lower delivery levels of maternal sRAGE were associated with a greater probability of longer gestation and delivery at term gestation. Higher-dose DHA supplementation increased the probability of a smaller decrease in delivery sRAGE levels. Higher IL-6 concentrations at delivery were associated with the probability of delivering after 37 weeks, and higher-dose DHA supplementation increased the probability of greater increases in IL-6 concentrations between enrollment and delivery. These data provide a proposed mechanistic explanation of how a higher dose of DHA during pregnancy provides immunomodulatory regulation in the initiation of parturition by influencing sRAGE and IL-6 levels, which may explain its ability to reduce the risk of preterm birth.

Effects of Docosahexaenoic Acid Supplementation During Pregnancy on Gestational Age and Size at Birth: Randomized, Double-Blind, Placebo-Controlled Trial in Mexico

2010 ◽  
Vol 31 (2_suppl2) ◽  
pp. S108-S116 ◽  
Author(s):  
Usha Ramakrishnan ◽  
Aryeh D. Stein ◽  
Socorro Parra-Cabrera ◽  
Meng Wang ◽  
Beth Imhoff-Kunsch ◽  
...  
Keyword(s):  
Docosahexaenoic Acid ◽  
Gestational Age ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Acid Supplementation ◽  
Size At Birth

scholarly journals The Kansas University DHA Outcomes Study (KUDOS) clinical trial: long-term behavioral follow-up of the effects of prenatal DHA supplementation

2019 ◽  
Vol 109 (5) ◽  
pp. 1380-1392 ◽  
Author(s):  
John Colombo ◽  
D Jill Shaddy ◽  
Kathleen Gustafson ◽  
Byron J Gajewski ◽  
Jocelynn M Thodosoff ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Preterm Birth ◽  
Visual Attention ◽  
Maternal Blood ◽  
Chain Polyunsaturated Fatty Acid ◽  
Long Term Effects ◽  
Double Blind ◽  
Early Preterm Birth

ABSTRACT Background Docosahexaenoic acid (DHA) is a long-chain polyunsaturated fatty acid that has been linked to improved vision and cognition in postnatal feeding studies and has been consistently associated with reduction of early preterm birth in prenatal supplementation trials. This is a report of the first long-term follow-up of infants from mothers receiving prenatal DHA supplementation in a US cohort. Objective Our objective was to evaluate the efficacy of the prenatal supplementation on both global and granular longitudinal assessments of cognitive and behavioral development. Methods In a randomized double-blind clinical trial, mothers received either 600 mg/d of DHA or a placebo beginning at 14.5 weeks of gestation and capsules were provided until delivery. Children from those pregnancies were followed by cognitive and behavioral assessments administered from 10 mo through 6 y of age. From 301 mothers in the initial study, ∼200 infants completed the longitudinal schedule. Results Although this intervention had been shown to reduce high-risk pregnancies and improve visual attention in infants during the first year, only a few positive long-term effects of prenatal DHA supplementation emerged from analyses of this follow-up. Increases in maternal blood DHA during pregnancy were related to verbal and full scale intelligence quotient (IQ) scores at 5 and 6 y, but these effects disappeared after controlling for SES. Maternal blood DHA concentrations at delivery were unrelated to outcomes, although maternal DHA at enrollment was related to productive vocabulary at 18 mo. Conclusions Although prenatal DHA supplementation substantially reduced early preterm birth and improved visual attention in infancy in this sample, no consistent long-term benefits were observed into childhood. Increases in maternal blood DHA concentration in pregnancy were related to higher IQs but this effect was confounded with SES and disappeared when SES was statistically controlled. This trial was registered at http://www.clinicaltrials.gov as NCT00266825 and NCT02487771.

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