Docosahexaenoic Acid Stability in Ready-to-Use Therapeutic Food.

Ready-to-use therapeutic food (RUTF) is used to treat young children diagnosed with severe acute malnutrition. RUTF with low and balanced linoleic and alpha-linolenic acid, plus omega-3 docosahexaenoic acid (DHA), supports long-term cognitive recovery. DHA is prone to degradation due to peroxidation, possibly exacerbated by the iron inherently in RUTF. Our goals were to prepare benchtop and manufacturing scale of RUTF formulations that include DHA and measure its retention. Twenty-seven RUTF formulas with base ingredients, including oats, high oleic or commodity peanuts, and encapsulated or oil-based DHA at various levels were prepared at benchtop scale, followed by seven months of climate-controlled storage. These pilot samples had similar relative DHA retention. At the manufacturing scale, DHA was added at one of two stages in the process, either at the initial or the final mixing stage. Samples taken at preliminary or later steps show that less than 20% of DHA added at the early stages disappeared prior to packaging for any recipe tested. Overall, our data indicate that most DHA included in RUTF is retained in the final product and that DHA is best retained when added at the latest manufacturing stage.

Supplementary Feeding of Moderately Wasted Children in Sierra Leone Reduces Severe Acute Malnutrition and Death When Compared with Nutrition Counseling: A Retrospective Cohort Study.

BACKGROUND: There is uncertainty about whether children with moderate wasting should receive supplementary feeding. OBJECTIVES: We examined whether supplementary feeding compared with counseling alone in children with moderate wasting prevented progression to severe acute malnutrition (SAM) or death. METHODS: This was a retrospective, dual-cohort study in which 1791 children with moderate wasting were drawn from 2 prior randomized controlled trials that took place in the same location in rural Sierra Leone. A total of 1077 children received supplementary feeding, whereas 714 children received counseling alone. Children in both cohorts were followed for ≥24 wk from enrollment. The primary outcome was time to SAM or death using Kaplan-Meier analysis. Secondary outcomes included time to death as well as proportions of children with healthy midupper arm circumference (MUAC), moderate wasting, SAM, or death at 6, 12, and 24 wk from enrollment. RESULTS: Children who received supplementary feeding were less likely to develop SAM or die across the entire follow-up period (HR: 0.53; 95% CI: 0.44, 0.65; P < 0.001). Time to event for death alone also revealed a lower risk for children who received supplementary feeding (HR: 0.52; 95% CI: 0.28, 0.94; P = 0.03). Children who received supplementary feeding were more likely to have a healthy MUAC at 6 wk (RR: 2.0; 95% CI: 1.7, 2.2) and 12 wk (RR: 1.3; 95% CI: 1.2, 1.5), were less likely to develop SAM at 6 (RR: 0.7; 95% CI: 0.6, 0.9), 12 (RR: 0.5; 95% CI: 0.3, 0.8), and 24 wk (RR: 0.2; 95% CI: 0.1, 0.5), and had higher rates of gain in weight and MUAC at 6 and 12 wk. CONCLUSIONS: Supplementary feeding of children with moderate wasting reduces risk of SAM and death across 24 wk of follow-up.

Supplementary Feeding of Moderately Wasted Children in Sierra Leone Reduces Severe Acute Malnutrition and Death When Compared with Nutrition Counseling: A Retrospective Cohort Study.

BACKGROUND: There is uncertainty about whether children with moderate wasting should receive supplementary feeding. OBJECTIVES: We examined whether supplementary feeding compared with counseling alone in children with moderate wasting prevented progression to severe acute malnutrition (SAM) or death. METHODS: This was a retrospective, dual-cohort study in which 1791 children with moderate wasting were drawn from 2 prior randomized controlled trials that took place in the same location in rural Sierra Leone. A total of 1077 children received supplementary feeding, whereas 714 children received counseling alone. Children in both cohorts were followed for ≥24 wk from enrollment. The primary outcome was time to SAM or death using Kaplan-Meier analysis. Secondary outcomes included time to death as well as proportions of children with healthy midupper arm circumference (MUAC), moderate wasting, SAM, or death at 6, 12, and 24 wk from enrollment. RESULTS: Children who received supplementary feeding were less likely to develop SAM or die across the entire follow-up period (HR: 0.53; 95% CI: 0.44, 0.65; P < 0.001). Time to event for death alone also revealed a lower risk for children who received supplementary feeding (HR: 0.52; 95% CI: 0.28, 0.94; P = 0.03). Children who received supplementary feeding were more likely to have a healthy MUAC at 6 wk (RR: 2.0; 95% CI: 1.7, 2.2) and 12 wk (RR: 1.3; 95% CI: 1.2, 1.5), were less likely to develop SAM at 6 (RR: 0.7; 95% CI: 0.6, 0.9), 12 (RR: 0.5; 95% CI: 0.3, 0.8), and 24 wk (RR: 0.2; 95% CI: 0.1, 0.5), and had higher rates of gain in weight and MUAC at 6 and 12 wk. CONCLUSIONS: Supplementary feeding of children with moderate wasting reduces risk of SAM and death across 24 wk of follow-up.

Low linoleic acid foods with added DHA given to Malawian children with severe acute malnutrition improve cognition: a randomized, triple-blinded, controlled clinical trial.

BACKGROUND: There is concern that the PUFA composition of ready-to-use therapeutic food (RUTF) for the treatment of severe acute malnutrition (SAM) is suboptimal for neurocognitive recovery. OBJECTIVES: We tested the hypothesis that RUTF made with reduced amounts of linoleic acid, achieved using high-oleic (HO) peanuts without added DHA (HO-RUTF) or with added DHA (DHA-HO-RUTF), improves cognition when compared with standard RUTF (S-RUTF). METHODS: A triple-blind, randomized, controlled clinical feeding trial was conducted among children with uncomplicated SAM in Malawi with 3 types of RUTF: DHA-HO-RUTF, HO-RUTF, and S-RUTF. The primary outcomes, measured in a subset of subjects, were the Malawi Developmental Assessment Tool (MDAT) global z-score and a modified Willatts problem-solving assessment (PSA) intention score for 3 standardized problems, measured 6 mo and immediately after completing RUTF therapy, respectively. MDAT domain z-scores, plasma fatty acid content, anthropometry, and eye tracking were secondary outcomes. Comparisons were made between the novel PUFA RUTFs and S-RUTF. RESULTS: Among the 2565 SAM children enrolled, mean global MDAT z-scores were -0.69 ± 1.19 and -0.88 ± 1.27 for children receiving DHA-HO-RUTF and S-RUTF, respectively (difference 0.19, 95% CI: 0.01, 0.38). Children receiving DHA-HO-RUTF had higher gross motor and social domain z-scores than those receiving S-RUTF. The PSA problem 3 scores did not differ by dietary group (OR: 0.92, 95% CI: 0.67, 1.26 for DHA-HO-RUTF). After 4 wk of treatment, plasma phospholipid EPA and α-linolenic acid were greater in children consuming DHA-HO-RUTF or HO-RUTF when compared with S-RUTF (for all 4 comparisons P values < 0.001), but only plasma DHA was greater in DHA-HO-RUTF than S-RUTF (P < 0.001). CONCLUSIONS: Treatment of uncomplicated SAM with DHA-HO-RUTF resulted in an improved MDAT score, conferring a cognitive benefit 6 mo after completing diet therapy. This treatment should be explored in operational settings. This trial was registered at clinicaltrials.gov as NCT03094247.

A novel intervention combining supplementary food and infection control measures to improve birth outcomes in undernourished pregnant women in Sierra Leone: A randomized, controlled clinical effectiveness trial.

BACKGROUND: Innovations for undernourished pregnant women that improve newborn survival and anthropometry are needed to achieve the Sustainable Development Goals 1 and 3. This study tested the hypothesis that a combination of a nutritious supplementary food and several proven chemotherapeutic interventions to control common infections would increase newborn weight and length in undernourished pregnant women. METHODS AND FINDINGS: This was a prospective, randomized, controlled clinical effectiveness trial of a ready-to-use supplementary food (RUSF) plus anti-infective therapies compared to standard therapy in undernourished pregnant women in rural Sierra Leone. Women with a mid-upper arm circumference (MUAC) ≤23.0 cm presenting for antenatal care at one of 43 government health clinics in Western Rural Area and Pujehun districts were eligible for participation. Standard of care included a blended corn/soy flour and intermittent preventive treatment for malaria in pregnancy (IPTp). The intervention replaced the blended flour with RUSF and added azithromycin and testing and treatment for vaginal dysbiosis. Since the study involved different foods and testing procedures for the intervention and control groups, no one except the authors conducting the data analyses were blinded. The primary outcome was birth length. Secondary outcomes included maternal weight gain, birth weight, and neonatal survival. Follow-up continued until 6 months postpartum. Modified intention to treat analyses was undertaken. Participants were enrolled and followed up from February 2017 until February 2020. Of the 1,489 women enrolled, 752 were allocated to the intervention and 737 to the standard of care. The median age of these women was 19.5 years, of which 42% were primigravid. Twenty-nine women receiving the intervention and 42 women receiving the standard of care were lost to follow-up before pregnancy outcomes were obtained. There were 687 singleton live births in the intervention group and 657 in the standard of care group. Newborns receiving the intervention were 0.3 cm longer (95% confidence interval (CI) 0.09 to 0.6; p = 0.007) and weighed 70 g more (95% CI 20 to 120; p = 0.005) than those receiving the standard of care. Those women receiving the intervention had greater weekly weight gain (mean difference 40 g; 95% CI 9.70 to 71.0, p = 0.010) than those receiving the standard of care. There were fewer neonatal deaths in the intervention (n = 13; 1.9%) than in the standard of care (n = 28; 4.3%) group (difference 2.4%; 95% CI 0.3 to 4.4), (HR 0.62 95% CI 0.41 to 0.94, p = 0.026). No differences in adverse events or symptoms between the groups was found, and no serious adverse events occurred. Key limitations of the study are lack of gestational age estimates and unblinded administration of the intervention. CONCLUSIONS: In this study, we observed that the addition of RUSF, azithromycin, more frequent IPTp, and testing/treatment for vaginal dysbiosis in undernourished pregnant women resulted in modest improvements in anthropometric status of mother and child at birth, and a reduction in neonatal death. Implementation of this combined intervention in rural, equatorial Africa may well be an important, practical measure to reduce infant mortality in this context. TRIAL REGISTRATION: ClinicalTrials.gov NCT03079388.

The effect of bovine colostrum/egg supplementation compared with corn/soy flour in young Malawian children: a randomized, controlled clinical trial.

BACKGROUND: Bovine colostrum with egg powder (BC/egg) is rich in essential amino acids and immunoactive compounds. OBJECTIVES: This trial tested the hypothesis that a daily supplement of BC/egg would reduce linear growth faltering and environmental enteric dysfunction (EED) in Malawian infants when compared with an isoenergetic ration of corn/soy flour used as a control. EED was defined by a lactulose permeability test. METHODS: This was a prospective, randomized, blinded, placebo-controlled clinical trial in which 9-mo-old infants received BC/egg or a control for 3 mo. The primary outcomes were change in length-for-age z-score (ΔLAZ) and urinary lactulose excretion (%L) at 12-mo-old. Secondary outcomes included episodes of diarrhea, stunting, EED, and the 16S configuration of the fecal microbiota. RESULTS: Of the 277 children enrolled, 267 completed the intervention phase of the study. LAZ decreased in all children from 9 to 17 mo, although ΔLAZ was less in children receiving BC/egg from 9 to 12 mo (difference = 0.12 z-scores; P = 0.0011). This difference persisted after feeding was completed, with less ΔLAZ (difference = 0.09 z-scores). A lower prevalence of stunting was seen in the intervention group (n = 47/137) than the control group (n = 62/127) at 17 mo (RR = 0.70; 95% CI: 0.52, 0.94).The median %L at 12 mo of age in the children receiving BC/egg was 0.14%, compared with 0.17% in the control group (P = 0.74). In children with %L >0.45% at enrollment (severe EED), the BC/egg group had more children with normal %L at 12 mo of age (10/20, 50%) than was seen in controls (2/15, 13%; P = 0.024). Episodes of diarrhea and ß-diversity of the 16S configuration of fecal microbiota did not differ between the 2 groups. CONCLUSIONS: Addition of BC/egg to complementary feeding in Malawian infants resulted in less linear growth faltering. This trial was registered at clinicaltrials.gov as NCT03801317.

Protein quality in ready-to-use supplementary foods for moderate wasting.

There are no guidelines for the optimal protein quality of ready-to-supplementary food (RUSF) for moderate acute malnutrition (MAM). This randomized, controlled, double-blinded, clinical effectiveness trial evaluated two RUSFs in the treatment of MAM. Both foods contained greater than 7% dairy protein, but the protein-optimized RUSF had a calculated digestible indispensable amino acid score (DIAAS) of 95%, whereas the control RUSF had a calculated DIAAS of 63%. There were 1,737 rural Malawian children 6-59 months of age treated with 75 kcal/kg/day of either control or protein quality-optimized RUSF for up to 12 weeks. There was no difference in the proportion of children who recovered from MAM between the group that received protein-optimized RUSF (759/860, 88%) and the group that received control RUSF (766/877, 87%, difference 1%, 95% CI, -2.1 to 4.1, p = 0.61). There were no differences in time to recovery or average weight gain; nor were adverse effects reported. Both RUSFs showed indistinguishable clinical outcomes, with recovery rates higher than typically seen in treatment for MAM. The DIAAS of these two RUSFs was measured using a pig model. Unexpectedly, the protein quality of the optimized RUSF was inferior to the control RUSF: DIAAS = 82% for the protein quality optimized RUSF and 96% for control RUSF. The controlled conditions of this trial suggest that in supplementary food products for MAM, protein quality is not an independent predictor of clinical effectiveness.

Treatment of severe acute malnutrition with oat or standard ready-to-use therapeutic food: a triple-blind, randomised controlled clinical trial.

OBJECTIVE: We hypothesised that an alternative RUTF (ready-to-use therapeutic food) made with oats (oat-RUTF) would be non-inferior to standard RUTF (s-RUTF). DESIGN: This was a randomised, triple-blind, controlled, clinical non-inferiority trial comparing oat-RUTF to s-RUTF in rural Sierra Leone. Children aged 6-59 months with severe acute malnutrition (SAM) were randomised to oat-RUTF or s-RUTF. s-RUTF was composed of milk powder, sugar, peanut paste and vegetable oil, with a hydrogenated vegetable oil additive. Oat-RUTF contained oats and no hydrogenated vegetable oil additives. The primary outcome was graduation, an increase in anthropometric measurements such that the child was not acutely malnourished. Secondary outcomes were rates of growth, time to graduation and presence of adverse events. Intention to treat analyses was used. RESULTS: Of the 1406 children were enrolled, graduation was attained in 404/721 (56%) children receiving oat-RUTF and 311/685 (45%) receiving s-RUTF (difference 10.6%, 95% CI 5.4% to 15.8%). Death, hospitalisation or remaining with SAM was seen in 87/721 (12%) receiving oat-RUTF and in 125/685 (18%) receiving s-RUTF (difference 6.2%, 95% CI 2.3 to 10.0, p=0.001). Time to graduation was less for children receiving oat RUTF; 3.9±1.8 versus 4.5±1.8 visits, respectively (p<0.001). Rates of weight in the oat-RUTF group were greater than in the s-RUTF group; 3.4±2.7 versus 2.5±2.3 g/kg/d, p<0.001. CONCLUSION: Oat-RUTF is superior to s-RUTF in the treatment of SAM in Sierra Leone. We speculate that might be because of beneficial bioactive components or the absence of hydrogenated vegetable oil in oat-RUTF. TRIAL REGISTRATION NUMBER: NCT03407326.

Role of Optimized Plant Protein Combinations as a Low-Cost Alternative to Dairy Ingredients in Foods for Prevention and Treatment of Moderate Acute Malnutrition and Severe Acute Malnutrition.

Tackling the global burden of acute malnutrition in children remains a major public health challenge and is essential for achieving sustainable development. Despite having effective treatment options, most wasted children go untreated; treatment coverage for severe acute malnutrition (SAM) children is only about 20%. Milk is currently an essential component of effective SAM treatment, incorporated into ready-to-use therapeutic food (RUTF). Reaching the untreated children, as well as preventing SAM, requires investment in innovative and cost-efficient approaches. To date, attempts to replace or remove milk from RUTF have been either unsuccessful or unpersuasive. This is likely because milk provides the highest protein quality and density of all typical RUTF ingredients. However, alternative protein sources could provide cost savings. Alternative protein sources, especially plant-based protein alternatives, have had shown more promising progress for the treatment of children with moderate acute malnutrition. Acknowledging that cost is a major barrier to the scale-up of treatment of acute malnutrition and that alternative protein sources are a practical means to reduce cost, continued research focusing on alternative proteins is necessary.

Alternative Ready-To-Use Therapeutic Food Yields Less Recovery Than the Standard for Treating Acute Malnutrition in Children From Ghana.

BACKGROUND: Only 20% of children with severe acute malnutrition (SAM) have access to ready-to-use therapeutic food (RUTF), and RUTF cost limits its accessibility. METHODS: This randomized, double-blind controlled study involved a clinical equivalence trial comparing the effectiveness of an alternative RUTF with standard RUTF in the home-based treatment of uncomplicated SAM and moderate malnutrition in Ghanaian children aged 6 to 59 months. The primary outcome was recovery, equivalence was defined as being within 5 percentage points of the control group, and an intention-to-treat analysis was used. Alternative RUTF was composed of whey protein, soybeans, peanuts, sorghum, milk, sugar, and vegetable oil. Standard RUTF included peanuts, milk, sugar, and vegetable oil. The cost of alternative RUTF ingredients was 14% less than standard RUTF. Untargeted metabolomics was used to characterize the bioactive metabolites in the RUTFs. RESULTS: Of the 1,270 children treated for SAM or moderate malnutrition, 554 of 628 (88%) receiving alternative RUTF recovered (95% confidence interval [CI]=85% to 90%) and 516 of 642 (80%) receiving standard RUTF recovered (95% CI=77% to 83%). The difference in recovery was 7.7% (95% CI=3.7% to 11.7%). Among the 401 children with SAM, the recovery rate was 130 of 199 (65%) with alternative RUTF and 156 of 202 (77%) with standard RUTF (P=.01). The default rate in SAM was 60 of 199 (30%) for alternative RUTF and 41 of 202 (20%) for standard RUTF (P=.04). Children enrolled with SAM who received alternative RUTF had less daily weight gain than those fed standard RUTF (2.4 ± 2.4 g/kg vs. 2.9 ± 2.6 g/kg, respectively; P<.05). Among children with moderate wasting, recovery rates were lower for alternative RUTF, 386 of 443 (87%), than standard RUTF, 397 of 426 (93%) (P=.003). More isoflavone metabolites were found in alternative RUTF than in the standard. CONCLUSION: The lower-cost alternative RUTF was less effective than standard RUTF in the treatment of severe and moderate malnutrition in Ghana.

Useful Tools for Food Aid: Linear Programming and Protein Quality Tools.

The development of a superior treatment option for severe acute malnutrition (SAM) which allowed for home-based therapy put in place constraints that are crucial for ensuring the feasibility and nutritional integrity of the treatment. Soon after the initial success of ready-to-use therapeutic food (RUTF), there were attempts to modify the formulation for cost and other areas of acceptability. While alternative formulations have been taken on in clinical trials, they have been inferior to the standard RUTF recipe. Linear programming (LP) technology, however, has streamlined the formulation process allowing the user to account for the crucial constraints required to maintain the feasibility and nutritional integrity of standard RUTF. With the aid of an LP tool and other functional tools for assessing nutrient quality, nutrition researchers can use innovative approaches in food development that could potentially revolutionize food aid products.

Milk Powder Added to a School Meal Increases Cognitive Test Scores in Ghanaian Children.

Background: The inclusion of milk in school feeding is accepted as good nutritional practice, but specific benefits remain uncertain. Objective: The objective was to determine whether consumption of 8.8 g milk protein/d given as milk powder with a multiple micronutrient-enriched porridge resulted in greater increases in linear growth and Cambridge Neuropsychological Test Automated Battery (CANTAB) scores in Ghanaian schoolchildren when compared with 1 of 3 control groups. Methods: A randomized, double-blind, placebo-controlled clinical trial in healthy children aged 6-9 y was conducted comparing 8.8 g milk protein/d with 4.4 g milk protein/d or 4.4 g milk protein + 4.4 g rice protein/d (isonitrogenous, half of the protein from milk and half from rice) or a non-nitrogenous placebo. Primary outcomes were changes in length after 9 mo and CANTAB scores after 4.5 mo; secondary outcomes were body-composition measures. Supplements were added to porridge each school day and consumed for 9 mo. Anthropometric and body-composition measures and CANTAB tests were completed upon enrollment and after 4.5 and 9 mo. Group results were compared by using ANCOVA for anthropometric measures and the Kruskal-Wallis test for CANTAB scores. Results: Children receiving 8.8 g milk protein/d showed greater increases on percentage correct in Pattern Recognition Memory (mean ± SD: 5.5% ± 16.8%; P < 0.05) and Intra/Extradimensional Set Shift completed stages compared with all other food groups (0.6 ± 2.3; P < 0.05). No differences were seen in linear growth between the groups. The children receiving either 4.4 or 8.8 g milk protein/d had a higher fat-free body mass index than those who received no milk, with an effect size of 0.34 kg/m2. Conclusion: Among schoolchildren, the consumption of 8.8 g milk protein/d improved executive cognitive function compared with other supplements and led to the accretion of more lean body mass, but not more linear growth. This trial was registered at www.clinicaltrials.gov">www.clinicaltrials.gov as NCT02757508.

Use of a novel supplementary food and measures to control inflammation in malnourished pregnant women in Sierra Leone to improve birth outcomes: study protocol for a prospective, randomized, controlled clinical effectiveness trial.

BACKGROUND: The negative synergy between poor nutritional status and infectious diseases is doubly detrimental in pregnancy. In Sierra Leone, maternal malnutrition is amongst the highest in the world, while maternal mortality is high at 1320/100,000 live births and stunting in under-five is 37.9%, ranked 110/132 worldwide. Maternal malnutrition has been associated with preterm birth, small-for-gestational age infants, and poor maternal outcomes. Infants born prematurely or small-for-gestational age experience higher mortality and are at risk for stunting and decreased cognitive performance. Nutritional interventions alone during pregnancy may not be as effective in the setting of increased inflammation from repeated infections. Interventions are needed to improve maternal outcomes and reduce stunting in this population. METHODS/DESIGN: This will be a prospective, randomized, controlled clinical effectiveness trial of an improved supplementary food plus anti-infective therapies compared to standard therapy in malnourished pregnant women. Pregnant women will be randomized to receive a low water activity, ready-to-use supplementary food plus five anti-infective interventions or the standard of care which is 3.5 kg corn/ soy blended flour with 350 mL vegetable oil every two weeks. The five anti-infective interventions are 1) insecticide-treated mosquito net at the time of enrollment into the study, 2) sulfadoxine-pyrimethamine given every 4 weeks, beginning at enrollment or at 13 weeks' gestation, whichever is later, 3)azithromycin at a dose of 1 g given once at enrollment (after first trimester)and again during 28-34 weeks of gestation, 4)single dose 400 mg albendazole given in second trimester, and 5) testing and treatment for bacterial vaginosis at enrollment and again at 28-34 weeks of gestation. Treatment will be provided for the duration of the pregnancy. The primary outcome measure will be birth length. Secondary outcomes in the mothers will include rates of maternal weight gain and increase in mid-upper arm circumference, and time to maternal anthropometric recovery. Secondary outcomes in the infants will include birth weight, birth head circumference, and linear and ponderal growth. DISCUSSION: Malnutrition remains a major problem in the developing world with lasting maternal and infant consequences. Maternal malnutrition has been associated with intrauterine growth retardation, low birth weight (LBW), pre-term delivery and poor cognitive development. Nutritional interventions alone have not been successful in reducing stunting. By bundling nutritional and anti-infective interventions, we aim to reduce intrauterine growth restriction and low birth weight in moderately malnourished pregnant women in Sierra Leone. If successful, this bundle can easily be implemented by governments or non-governmental organizations. TRIAL REGISTRATION: Clinicaltrials.gov NCT03079388; Date: March 5, 2017.

Adolescent pregnancy and nutrition: a subgroup analysis from the Mamachiponde study in Malawi.

Young age at childbearing (≤19 years) is common and associated with poor birth outcomes. A trial among Malawian pregnant women with moderate malnutrition was used to determine outcomes of young adolescents (≤18 years), older adolescents (18-20 years), and adults (>20 years). Women received one of three supplementary foods that provided ∼900 kcal/day and 33-36 g protein/day and returned every 2 weeks. Newborn/maternal measurements were taken at delivery and after 6 and 12 weeks. Upon enrollment, adolescents had greater body mass index than adults (19.9 ± 1.3 versus 19.5 ± 1.4 kg/m2 , P < 0.001). Young adolescents received more rations of food and enrolled and delivered with a lower fundal height than adults (21.7 ± 5.2 versus 23.0 ± 5.6, P = 0.00 enrollment; 30.2 ± 3.1 versus 31.0 ± 2.8, P < 0.001 delivery). Among newborns, length for age was lowest in young adolescents, greater in older adolescents, and greatest in adults (Z-scores -1.7 ± 1.2, -1.4 ± 1.2, and -1.1 ± 1.1, respectively; P < 0.001). These differences persisted in length for age at 6 and 12 weeks of age for infants. Adolescents enrolled earlier in pregnancy and appeared more nutritionally adequate than adults; adolescent outcomes were inferior to those of adults, suggesting that they were subject to more physiologic stressors and/or different nutritional needs.

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

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.