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Trial of ready-to-use supplemental food and corn-soy blend in pregnant Malawian women with moderate malnutrition: a randomized controlled clinical trial.

ABSTRACT: Background:Malnutrition during pregnancy in sub-Saharan Africa is associated with poor birth outcomes. Objective:This study compared maternal and offspring anthropometry for moderately malnourished pregnant women receiving ready-to-use supplemental food (RUSF), a fortified corn-soy blend (CSB+) with a daily multiple micronutrient antenatal supplement [United Nations International Multiple Micronutrient Preparation (UNIMMAP)], or standard of care comprising CSB+ and iron and folic acid (IFA). Design:A single-blind randomized controlled clinical trial was conducted in southern Malawi among 1828 pregnant women with moderate malnutrition, defined as a midupper arm circumference (MUAC) ?20.6 and ?23.0 cm. Women received 1 of 3 dietary treatment regimens that provided ?900 kcal/d and 33-36 g protein/d. Maternal and infant anthropometry were followed until the child was 3 mo old. Results:Newborns had a mean length-for-age z score of -1.3 ± 1.2 and 22% were stunted at birth. Mothers receiving RUSF had the highest weight gain during supplementation (3.4 ± 2.6, 3.0 ± 2.2, and 3.2 ± 2.4 kg for the RUSF, CSB+ with UNIMMAP, and CSB+ with IFA groups, respectively; P = 0.03). Newborn birth weights and lengths were similar across intervention groups, but the incidence of newborns with a birth weight <2.4 kg (weight-for-age z score <-2) was higher in the CSB+ with UNIMMAP group than the other groups (17%, 18%, and 24% for the CSB+ with IFA, RUSF, and CSB+ with UNIMMAP groups, respectively; P = 0.02). At birth, HIV-exposed newborns had a similar length and weight as newborns without HIV exposure, but their head circumference was smaller (34.0 ± 1.5 and 34.3 ± 1.6 cm, respectively; P = 0.02). At 3 mo of age, HIV-exposed infants had smaller weights, lengths, and head and arm circumferences than infants without HIV exposure. Conclusions:RUSF improved maternal weight gain compared with CSB+ with UNIMMAP. The large amount of food given and the modest effect on linear growth in newborns suggests that stunting in utero is unlikely to be reduced by supplemental food alone. This trial was registered at clinicaltrials.gov as NCT02120599.

SUBMITTER: Callaghan-Gillespie M

PROVIDER: S-EPMC6483045 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Trial of ready-to-use supplemental food and corn-soy blend in pregnant Malawian women with moderate malnutrition: a randomized controlled clinical trial.

Callaghan-Gillespie Meghan M Schaffner Andrew A AA Garcia Patsy P Fry Jocelyn J Eckert Rachael R Malek Shirin S Trehan Indi I Thakwalakwa Chrissie C Maleta Kenneth M KM Manary Mark J MJ Papathakis Peggy C PC

The American journal of clinical nutrition 20171001 4

<h4>Background</h4>Malnutrition during pregnancy in sub-Saharan Africa is associated with poor birth outcomes.<h4>Objective</h4>This study compared maternal and offspring anthropometry for moderately malnourished pregnant women receiving ready-to-use supplemental food (RUSF), a fortified corn-soy blend (CSB+) with a daily multiple micronutrient antenatal supplement [United Nations International Multiple Micronutrient Preparation (UNIMMAP)], or standard of care comprising CSB+ and iron and folic ...[more]

PMID: 28793991

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Project description:Zinc deficiency is common among children with Moderate Acute Malnutrition (MAM) and contributes to growth failure, increased morbidity and mortality. Diarrhoea and poor dietary practices are the main causes of zinc deficiency. Corn-soy Blend (CSB), the standard product in management of children with MAM has a limitation of poor micronutrient bioavailability. Micronutrient powders (MNPs) which are added at the point of consumption have a potential in improving micronutrient status however, scientific evidence on efficacy on improving the zinc status is scarce. A cluster-randomized clinical trial was designed to establish bioequivalence of MNPs to CSB on serum zinc status among children (6-36 months) with MAM in Thika informal settlements, Kenya. Sample size was calculated to show bioequivalence within ±20% limit. Twelve villages were randomized to four study groups. Three experimental groups received different formulations of MNPs added to unfortified CSB porridge as; multiple micronutrients containing zinc (CSB-MNP-A n = 84), multiple micronutrients without zinc (CSB-MNP-B n = 88) and zinc only (CSB-MNP-C n = 94). Control group (n = 80) received standard CSB fortified with multiple micronutrients. Standard amount of CSB was consumed in feeding centres for six months. Serum zinc concentration was assessed pre- and post-intervention. Data was analyzed based on treatment assignment regardless of adherence and drop-out status. Mixed effects linear regression was used to model pre-post change in serum zinc concentration, adjusting for clustering effect and baseline differences. Bioequivalence was assessed using two one-sided t-tests. At baseline, 84.4% were zinc deficient (serum zinc <65μg/dL) and zinc intake was sub-optimal (<3 mg/day) for 95.7% of children. Mean change in serum zinc concentration was significantly higher (p = 0.024) in CSB-MNP-A (18.7 ± 2.1) μg/dL compared to control group (11.8 ± 2.6 μg/dL). MNPs are not bioequivalent to CSB within the ±20% bioequivalence limit. MNPs are more effective in improving serum zinc status compared to CSB. Trials with larger sample sizes are recommended to validate the current findings. Trial registration: Pan African Clinical Trials Registry: PACTR201907492232376.

Dataset Information

Trial of ready-to-use supplemental food and corn-soy blend in pregnant Malawian women with moderate malnutrition: a randomized controlled clinical trial.

Publications

Trial of ready-to-use supplemental food and corn-soy blend in pregnant Malawian women with moderate malnutrition: a randomized controlled clinical trial.

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