Fortified balanced energy–protein supplementation during pregnancy and lactation and infant growth in rural Burkina Faso: A 2 × 2 factorial individually randomized controlled trial

Argaw, Alemayehu; Kok, Brenda de; Toe, Laeticia Celine; Hanley-Cook, Giles; Dailey-Chwalibóg, Trenton; Ouédraogo, Moctar; Compaoré, Anderson; Vanslambrouck, Katrien; Ganaba, Rasmané; Kolsteren, Patrick; Lachat, Carl; Huybregts, Lieven

doi:10.1371/journal.pmed.1004186

Cited by 12 publications

(10 citation statements)

References 49 publications

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“…The observed effects of prenatal BEP on newborn FFMI can be seen in relation to the subsequent modest effect of prenatal BEP on linear growth achieved at 6 months of age (0.11 z-score; 95% CI: 0.01, 0.21; p = 0.032) that we reported previously [ 52 ]. In Ethiopia, Admassu and colleagues [ 53 ] found that newborn FFM, but not FM, was positively associated with height-for-age z-score at 2 years of age.…”

Section: Discussionsupporting

confidence: 67%

Effect of prenatal micronutrient-fortified balanced energy-protein supplementation on maternal and newborn body composition: A sub-study from the MISAME-III randomized controlled efficacy trial in rural Burkina Faso

et al. 2023

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Background Micronutrient-fortified balanced energy-protein (BEP) supplements are promising interventions to prevent intrauterine growth retardation in low- and middle-income countries. On the other hand, one concern with blanket prenatal supplementation programs using energy-dense supplements is that they could lead to more maternal and/or infant overweight. However, evidence is lacking on the potential effect of BEP on maternal and offspring body composition. This study evaluates the effects of micronutrient-fortified BEP supplementation during pregnancy on body composition of mothers and their newborns in rural Burkina Faso. Methods and findings The MISAME-III study is an open label individually randomized controlled trial where pregnant women (n = 1,897) of gestational age <21 weeks received either a combination of micronutrient-fortified BEP and iron-folic acid (IFA) tablets (i.e., intervention) or IFA alone (i.e., control). The prenatal phase of the MISAME-III study was conducted between the first enrollment in October 2019 and the last delivery in August 2021. In a sub-study nested under the MISAME-III trial, we evaluated anthropometry and body composition in newborns who were born starting from 17 November 2020 (n: control = 368 and intervention = 352) and their mothers (n: control = 185 and intervention = 186). Primary study outcomes were newborn and maternal fat-free mass (FFMI) and fat-mass (FMI) indices. We used the deuterium dilution method to determine FFMI and FMI and %FFM and %FM of total body weight within 1 month postpartum. Our main analysis followed a modified intention-to-treat approach by analyzing all subjects with body composition data available. Univariable and multivariable linear regression models were fitted to compare the intervention and control arms, with adjusted models included baseline maternal age, height, arm fat index, hemoglobin concentration and primiparity, household size, wealth and food security indices, and newborn age (days). At study enrollment, the mean ± SD maternal age was 24.8 ± 6.13 years and body mass index (BMI) was 22.1 ± 3.02 kg/m2 with 7.05% of the mothers were underweight and 11.5% were overweight. Prenatal micronutrient-fortified BEP supplementation resulted in a significantly higher FFMI in mothers (MD (mean difference): 0.45; 95% CI (confidence interval): 0.05, 0.84; P = 0.026) and newborns (MD: 0.28; 95% CI: 0.06, 0.50; P = 0.012), whereas no statistically significant effects were found on FMI. The effect of micronutrient-fortified BEP on maternal FFMI was greater among mothers from food secure households and among those with a better nutritional status (BMI ≥21.0 kg/m2 or mid-upper arm circumference (MUAC) ≥23 cm). Key limitations of the study are the relatively high degree of missing data (approximately 18%), the lack of baseline maternal body composition values, and the lack of follow-up body composition measurements to evaluate any long-term effects. Conclusions Micronutrient-fortified BEP supplementation during pregnancy can increase maternal and newborn FFMI, without significant effects on FMI. Trial registration ClinicalTrials.gov with identifier NCT03533712.

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Section: Discussionsupporting

confidence: 67%

Effect of prenatal micronutrient-fortified balanced energy-protein supplementation on maternal and newborn body composition: A sub-study from the MISAME-III randomized controlled efficacy trial in rural Burkina Faso

et al. 2023

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“…The primary outcomes were the prevalence of SGA at birth (<10th percentile of the newborns size standards of the International Fetal and Newborn Growth Consortium for the 21st Century (INTERGROWTH-21st) [ 9 ] (Villar et al, 2013)) and the length-for-age z-score (LAZ) at 6 months of age (calculated using the WHO’s 2006 growth reference at 6 months of age [ 10 ] (de Onis and Branca, 2016)). These results have been published [ 11 , 12 , 13 ] (de Kok et al, 2022; Argaw, de Kok, et al, 2023; Argaw, Toe, et al, 2023).…”

Section: Introductionsupporting

confidence: 70%

A Multi-Omics and Human Biomonitoring Approach to Assessing the Effectiveness of Fortified Balanced Energy–Protein Supplementation on Maternal and Newborn Health in Burkina Faso: A Study Protocol

Bastos-Moreira,

Ouédraogo,

De Boevre

et al. 2023

Nutrients

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Fortified balanced energy–protein (BEP) supplementation is a promising intervention for improving maternal health, birth outcomes and infant growth in low- and middle-income countries. This nested biospecimen sub-study aimed to evaluate the physiological effect of multi-micronutrient-fortified BEP supplementation on pregnant and lactating women and their infants. Pregnant women (15–40 years) received either fortified BEP and iron–folic acid (IFA) (intervention) or IFA only (control) throughout pregnancy. The same women were concurrently randomized to receive either a fortified BEP supplement during the first 6 months postpartum in combination with IFA for the first 6 weeks (i.e., intervention) or the postnatal standard of care, which comprised IFA alone for 6 weeks postpartum (i.e., control). Biological specimens were collected at different timepoints. Multi-omics profiles will be characterized to assess the mediating effect of BEP supplementation on the different trial arms and its effect on maternal health, as well as birth and infant growth outcomes. The mediating effect of the exposome in the relationship between BEP supplementation and maternal health, birth outcomes and infant growth were characterized via biomonitoring markers of air pollution, mycotoxins and environmental contaminants. The results will provide holistic insight into the granular physiological effects of prenatal and postnatal BEP supplementation.

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“…However, iron and folic acid supplementation in the form of BEP or IFA tablets formulations did not improve anemia prevalence during pregnancy (60). Similarly, there was a high prevalence of infant anemia at 6 months of age in both intervention and control groups (61) suggesting the limited effect of maternal iron and folic acid supplementations in the form of BEP and IFA tablets formulations. On the other hand, the exploratory analysis here indicated a beneficial role of BEP in mitigating the negative effect of OTA exposure on increased infant anemia at the age of 6 months.…”

Section: Discussionmentioning

confidence: 99%

Ochratoxin A status at birth is associated with reduced birthweight and ponderal index in rural Burkina Faso

Bastos-Moreira,

Argaw,

Di Palma

et al. 2024

Preprint

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Background: Mycotoxin exposure during pregnancy has been associated with adverse birth outcomes and poor infant growth. We assessed multiple biomarkers and metabolites of exposure to mycotoxins at birth and their associations with birth outcomes and infant growth in 274 newborns in rural Burkina Faso. Methods and findings: Whole blood microsamples were analyzed for mycotoxin concentrations in newborns in the Biospecimen sub-study nested in MISAME-III trial using ultra performance liquid chromatography coupled to tandem mass spectrometry. Unadjusted and adjusted associations between mycotoxin exposure, and birth outcomes and infant growth at 6 months were estimated using linear regression models for continuous outcomes and linear probability models with robust variance estimation for binary outcomes. Infant growth trajectories from birth to 6 months were compared by exposure status using mixed-effects models with random intercept for the individual infant and random slope for the age of the infant. Ochratoxin A (OTA) exposure was detected in 38.3% of newborns, with other mycotoxins being detected in the range of 0.36% and 4.01%. OTA exposure was significantly associated with adverse birth outcomes, such as lower birthweight (β (95% CI): -0.11 kg (-0.21, 0.00); p = 0.042) and ponderal index ( β(95% CI): -0.62 gm/cm3 (-1.19, -0.05); p = 0.034), and a marginally significant lower height growth trajectories during the first 6 months (β(95% CI): -0.08 cm/mo (-0.15, 0.0); p = 0.057) . Conclusions: OTA exposure was prevalent among newborns and also associated with lower growth at birth and during the first 6 months. The results emphasize the importance of nutrition-sensitive strategies to mitigate dietary OTA, as well as adopting food safety measures in Burkina Faso during the fetal period of development.

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Fortified balanced energy–protein supplementation during pregnancy and lactation and infant growth in rural Burkina Faso: A 2 × 2 factorial individually randomized controlled trial

Cited by 12 publications

References 49 publications

Effect of prenatal micronutrient-fortified balanced energy-protein supplementation on maternal and newborn body composition: A sub-study from the MISAME-III randomized controlled efficacy trial in rural Burkina Faso

Effect of prenatal micronutrient-fortified balanced energy-protein supplementation on maternal and newborn body composition: A sub-study from the MISAME-III randomized controlled efficacy trial in rural Burkina Faso

A Multi-Omics and Human Biomonitoring Approach to Assessing the Effectiveness of Fortified Balanced Energy–Protein Supplementation on Maternal and Newborn Health in Burkina Faso: A Study Protocol

Ochratoxin A status at birth is associated with reduced birthweight and ponderal index in rural Burkina Faso

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