Growth and adiposity in newborns study (GAINS): The influence of prenatal DHA supplementation protocol

Contemp Clin Trials. 2023 Sep:132:107279. doi: 10.1016/j.cct.2023.107279. Epub 2023 Jul 3.

Abstract

Background: Obesity and central fat mass (FM) accrual drive disease development and are related to greater morbidity and mortality. Excessive gestational weight gain (GWG) increases fetal fat accretion resulting in greater offspring FM across the lifespan. Studies associate greater maternal docosahexaenoic acid (DHA) levels with lower offspring FM and lower visceral adipose tissue during childhood, however, most U.S. pregnant women do not consume an adequate amount of DHA. We will determine if prenatal DHA supplementation is protective for body composition changes during infancy and toddlerhood in offspring exposed to excessive GWG.

Methods and design: Infants born to women who participated in the Assessment of DHA on Reducing Early Preterm Birth randomized controlled trial (ADORE; NCT02626299) will be invited to participate. Women were randomized to either a high 1000 mg or low 200 mg daily prenatal DHA supplement starting in the first trimester of pregnancy. Offspring body composition and adipose tissue distribution will be measured at 2 weeks, 6 months, 12 months, and 24 months using dual energy x-ray absorptiometry. Maternal GWG will be categorized as excessive or not excessive based on clinical guidelines.

Discussion: Effective strategies to prevent obesity development are lacking. Exposures during the prenatal period are important in the establishment of the offspring phenotype. However, it is largely unknown which exposures can be successfully targeted to have a meaningful impact. This study will determine if prenatal DHA supplementation modifies the relationship between maternal weight gain and offspring FM and FM distribution at 24 months of age.

Ethics and dissemination: The University of Kansas Medical Center Institutional Review Board (IRB) approved the study protocol (STUDY00140895). The results of the trial will be disseminated at conferences and in peer reviewed publications.

Trial registration: ClinicalTrials.gov ID: NCT03310983.

Keywords: Adipose tissue distribution; Body composition; Docosahexaenoic acid; Growth; Pregnancy.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adiposity
  • Dietary Supplements
  • Docosahexaenoic Acids / therapeutic use
  • Female
  • Gestational Weight Gain*
  • Humans
  • Infant, Newborn
  • Obesity
  • Pregnancy
  • Premature Birth* / prevention & control
  • Randomized Controlled Trials as Topic
  • Vitamins
  • Weight Gain

Substances

  • Docosahexaenoic Acids
  • Vitamins

Associated data

  • ClinicalTrials.gov/NCT03310983