Abstract
BackgroundResearch directed to optimizing maternal nutrition commencing prior to conception remains very limited, despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy.Methods/Study designThis is an individually randomized controlled trial of the impact on birth length (primary outcome) of the time at which a maternal nutrition intervention is commenced: Arm 1: ≥ 3 mo preconception vs. Arm 2: 12-14 wk gestation vs. Arm 3: none.192 (derived from 480) randomized mothers and living offspring in each arm in each of four research sites (Guatemala, India, Pakistan, Democratic Republic of the Congo). The intervention is a daily 20 g lipid-based (118 kcal) multi-micronutient (MMN) supplement. Women randomized to receive this intervention with body mass index (BMI) <20 or whose gestational weight gain is low will receive an additional 300 kcal/d as a balanced energy-protein supplement. Researchers will visit homes biweekly to deliver intervention and monitor compliance, pregnancy status and morbidity; ensure prenatal and delivery care; and promote breast feeding. The primary outcome is birth length. Secondary outcomes include: fetal length at 12 and 34 wk; incidence of low birth weight (LBW); neonatal/infant anthropometry 0-6 mo of age; infectious disease morbidity; maternal, fetal, newborn, and infant epigenetics; maternal and infant nutritional status; maternal and infant microbiome; gut inflammatory biomarkers and bioactive and nutritive compounds in breast milk. The primary analysis will compare birth Length-for-Age Z-score (LAZ) among trial arms (independently for each site, estimated effect size: 0.35). Additional statistical analyses will examine the secondary outcomes and a pooled analysis of data from all sites.DiscussionPositive results of this trial will support a paradigm shift in attention to nutrition of all females of child-bearing age.Trial registrationClinicalTrials.gov NCT01883193.
Highlights
Research directed to optimizing maternal nutrition commencing prior to conception remains very limited, despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy
Maternal intervention trials have not begun in the first trimester or/and the periconceptional period despite observational evidence of a relationship between poor maternal nutrition at conception and low birth weight (LBW) first reported a quarter of a century ago [5]
A series of observational and experimental studies suggest that intra-uterine growth retardation (IUGR), preterm birth (PTB) and stillbirths have their origins in part in early pregnancy [6,7,8]
Summary
Research directed to optimizing maternal nutrition commencing prior to conception remains very limited, despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy. Low maternal weight gain in early pregnancy, indicative of sub-optimal maternal nutrition, has been reported to be a specific cause of LBW attributable to effects on both length of gestation and on fetal growth velocity [9]. An intervention improving maternal nutritional status and maternal weight in early pregnancy was associated with a positive effect on birth length which was not observed with nutrition interventions starting later in pregnancy [9]. When the intervention was started in the first trimester (average of 9 wk gestational age), the beneficial effects on birth weight and even on offspring mortality were significantly greater than when the same intervention was commenced at 20 wk. Maternal-infant bonding and perception of food insecurity benefited from the first trimester start [11]
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