Growth from Birth Through Six Months for Infants of Mothers in the "Women First" Preconception Maternal Nutrition Trial.
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ABSTRACT: Objective
To evaluate whether the fetal linear growth effects of maternal nutrition supplementation would be maintained through 6 months postnatal age.Study design
The Women First trial was a multicountry, individually randomized clinical trial that compared the impact of maternal nutrition supplementation initiated preconception (Arm 1) vs at ∼11 weeks of gestation (Arm 2), vs no supplement (Arm 3); the intervention was discontinued at delivery. Trial sites were in Democratic Republic of Congo, Guatemala, India, and Pakistan. Analysis includes 2421 infants born to 2408 randomized women. Primary outcome was the trajectory of length-for-age z scores (LAZ) by arm, based on assessments at birth and 1, 3, and 6 months. We fitted longitudinal models on growth from birth to 6 months using generalized estimating equations; maternal intervention effects were evaluated, adjusting for site and baseline maternal covariates.Results
Linear growth for Arms 1 and 2 was statistically greater than for Arm 3 in 3 of the 4 countries, with average pairwise mean differences in LAZ of 0.25 (95% CI 0.15-0.35; P < .001) and 0.19 (95% CI 0.09-0.28; P < .001), respectively. Compared with Arm 3, average overall adjusted relative risks (95% CI) for stunting (LAZ <-2) were lower for Arms 1 and 2: 0.76 (0.66-0.87; P < .001) and 0.77 (0.67-0.88; P < .001), respectively.Conclusions
Improved linear growth in early infancy observed for the 2 intervention arms supports the critical importance of maternal nutrition before conception and in the early phase of gestation.Trial registration
ClinicalTrials.gov: NCT01883193.
SUBMITTER: Krebs NF
PROVIDER: S-EPMC7855785 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Abstract Objectives Newborn size, including length, has been associated with later growth. Preconception nutrition supplementation in Women First (WF) trial (clinicaltrials.gov NCT01883193) was associated with higher newborn length and lower rates of stunting. The objective was to examine postnatal growth outcomes through 6 mo in the WF offspring. Methods Subjects were 2450 infants from the WF sites in Democratic Republic of Congo (DRC), Guatemala, India, and Pakistan with the 3 WF arms maintained: Arm 1 started a lipid-based nutrition supplement ≥ 3 mo prior to conception; Arm 2 started same supplement at ∼11 wk gestation; and Arm 3 received no trial supplements. Maternal supplementation was discontinued at delivery. Anthropometric measurements were obtained at birth, 0.5, 1, 3, and 6 mo; Z-scores were calculated from WHO Child Growth Standards. Primary and secondary outcomes were analyzed using longitudinal generalized estimating equations accounting for the correlation of repeated measures over time and study cluster. Intervention effects were evaluated within each site as well as overall, adjusting for site and baseline maternal covariates that differed by arm. Statistical interaction between arm and infant sex was evaluated and included if significant. Results Longitudinal growth (length and weight) curves from 0–6 mo demonstrated differences by intervention arm, with Arms 1 and 2 more favorable compared to Arm 3 (Table + LAZ in Figure). Relative risks (RR) for stunting were significantly lower for Arms 1 and 2 (vs. Arm 3) (Table). Site-specific analyses revealed some site differences warranting further exploration. Conclusions Without any postnatal intervention, differences in fetal growth evident at birth persisted at 6 months. Funding Sources Bill & Melinda Gates Foundation; NIH, NICHD & ODS. Supporting Tables, Images and/or Graphs
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Project description:Maternal iodine (I) status is critical in embryonic and foetal development. We examined the effect of preconception iodine supplementation on maternal iodine status and on birth outcomes. Non-pregnant women in Guatemala, India and Pakistan (n ~ 100 per arm per site) were randomized ≥ 3 months prior to conception to one of three intervention arms: a multimicronutrient-fortified lipid-based nutrient supplement containing 250-μg I per day started immediately after randomization (Arm 1), the same supplement started at ~12 weeks gestation (Arm 2) and no intervention supplement (Arm 3). Urinary I (μg/L) to creatinine (mg/dl) ratios (I/Cr) were determined at 12 weeks for Arm 1 versus Arm 2 (before supplement started) and 34 weeks for all arms. Generalized linear models were used to assess the relationship of I/Cr with arm and with newborn anthropometry. At 12 weeks gestation, adjusted mean I/Cr (μg/g) for all sites combined was significantly higher for Arm 1 versus Arm 2: (203 [95% CI: 189, 217] vs. 163 [95% CI: 152, 175], p < 0.0001). Overall adjusted prevalence of I/Cr < 150 μg/g was also lower in Arm 1 versus Arm 2: 32% (95% CI: 26%, 38%) versus 43% (95% CI: 37%, 49%) (p = 0.0052). At 34 weeks, adjusted mean I/Cr for Arm 1 (235, 95% CI: 220, 252) and Arm 2 (254, 95% CI: 238, 272) did not differ significantly but were significantly higher than Arm 3 (200, 95% CI: 184, 218) (p < 0.0001). Nominally significant positive associations were observed between I/Cr at 12 weeks and birth length and head circumference z-scores (p = 0.028 and p = 0.005, respectively). These findings support the importance of first trimester iodine status and suggest need for preconception supplementation beyond salt iodization alone.
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