Nutritional treatment of children 6-59 months with severely low weight-for-age z-score: a study protocol for a 3-arm randomized controlled trial.

BACKGROUND: Admission criteria that treat children with low mid-upper-arm circumference (MUAC), and low weight-for-height z-score (WHZ) are not aligned with the evidence on which children are at risk of mortality. An analysis of community-based cohort data from Senegal found that a combination of weight-for-age (WAZ) and MUAC criteria identified all children at risk of near-term death associated with severe anthropometric deficits. This study will address whether children with WAZ <-3 but MUAC ≥125 mm benefit from therapeutic feeding with ready-to-use therapeutic foods (RUTF) and whether a simplified protocol is non-inferior to the weight-based standard protocol. METHODS: This is a prospective individually randomized controlled 3-arm trial conducted in the Nara health district in Mali. Children aged 6-59 months presenting with MUAC ≥125 mm and WAZ <-3 will be randomized to (1) control group receiving no treatment, (2) simplified treatment receiving 1 sachet of RUTF daily until WAZ ≥-3 for 2 visits, (3) standard treatment receiving RUTF according to WHZ category: (a) WHZ <-3 receive 200 kcal/kg/day until WHZ ≥-2 for 2 visits, (b) WHZ ≥-3 but <-2 receive 1 sachet daily until WHZ ≥-2 for 2 visits or (c) WHZ ≥-2 receive no treatment. All children will be followed up first fortnightly for 12 weeks and then monthly until 6 months post-enrolment. The primary endpoint will be measured at 2 months with the primary outcome being WAZ as a continuous measure. Other outcomes include other anthropometric measurements and a secondary endpoint will be observed at 6 months. A total of 1397 children will be recruited including 209 in the control and 594 in both the simplified and standard arms. The sample size should enable us to conclude on the superiority of the simplified treatment compared to no treatment and on the non-inferiority of the simplified treatment versus standard treatment with a margin of non-inferiority of 0.2 WAZ. DISCUSSION: This trial aims to generate new evidence on the benefit of treating children with WAZ <-3 but MUAC ≥125 mm in order to guide the choice of admission criteria to malnutrition treatment and build evidence on the most efficient treatment protocol. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov: NCT05248516 on February 21, 2022.

Risk factors for moderate acute malnutrition among children with acute diarrhoea in India and Tanzania: a secondary analysis of data from a randomized trial.

BACKGROUND: Moderate acute malnutrition (MAM) affects over 30 million children aged < 5 years worldwide. MAM may confer a greater risk of developing severe malnutrition and even mortality in children. Assessing risk factors for MAM may allow for earlier recognition of children at risk of deleterious health outcomes. OBJECTIVE: To determine risk factors associated with the prevalence and development of MAM among children aged 6 to 59 months with acute diarrhoea who received treatment with oral rehydration solution and zinc supplementation. METHODS: We conducted a secondary analysis of data from a randomized, dose-finding trial of zinc among children with acute diarrhoea in India and Tanzania. We used regression models to assess risk factors for prevalent MAM at the start of diarrhoea treatment and to identify risk factors associated with the development of MAM at 60 days. MAM was defined as weight for length (or height) Z score ≤-2 and > -3 or mid-upper arm circumference < 12.5 and ≥ 11.5 cm. RESULTS: A total of 4,500 children were enrolled; 593 (13.2%) had MAM at the baseline. MAM at baseline was significantly less common among children in Tanzania than in India (adjusted risk ratio [aRR] 0.37, 95% confidence interval [CI]: 0.30, 0.44, P < 0.001), in children aged 24- < 60 months versus 6- < 12 months (aRR 0.46, 95% CI: 0.38, 0.56, P < 0.001), and in families with household wealth index higher than the median (aRR 0.79, 95% CI: 0.68, 0.92, P = 0.002). Sixty days after outpatient treatment and follow-up, 87 (2.5%) children developed MAM. When compared to children aged 6- < 12 months, children aged 24- < 60 months had a 52% lower risk of developing MAM. Every one unit increase in weight for length (or height) Z score at enrolment was associated with a 93% lower risk of developing MAM during follow-up. CONCLUSIONS: Among children with diarrhoea, younger children and those from households with lower wealth were at greater risk of MAM. These children may benefit from targeted interventions focusing on feeding (targeted nutrition support for at-risk households) and follow up in order to reduce the occurrence of MAM and its consequences.

Efficacy of ready-to-use food supplement for treatment of moderate acute malnutrition among children aged 6 to 59 months.

Moderate acute malnutrition (MAM) is a persistent public health problem in Tanzania. The current approach for its management is nutrition counselling. However, there has been no commercial production of ready-to-use supplementary foods for the management of MAM in the country but rather imported from companies outside the country. The objective of the study was to determine the ability of a ready-to-use food supplementation versus corn soya blend (CSB+) to manage MAM. The randomised controlled trial employed three parallel arm approach. The first arm received CSB+ and infant and young child feeding (IYCF) counselling, the second arm received ready-to-use food (RUF) and IYCF counselling and the third arm, a control group, received IYCF as standard care for three consecutive months. Results indicated that the overall proportion of children who recovered from MAM was 65.6%. There was a significant difference (p < 0.001) in the proportion of children who recovered from MAM between the three arms (CSB+, RUF and standard care). Results revealed further a high recovery rate of 83.7% in the RUF arm, followed by 71.9% in the CSB+ arm and 41% in the standard care arm. The risk differences for RUF compared with CSB+ and standard care were 11.8% and 42.7%, respectively. RUFs can be used as an alternative supplement to conventional CSB+ for the management of MAM in children and, thus, has the potential to scale up its use to address the problem of MAM among 6 to 59 months' children.

Post-Recovery Relapse of Children Treated with a Simplified, Combined Nutrition Treatment Protocol in Mali: A Prospective Cohort Study.

The present study aimed to determine the 6-month incidence of relapse and associated factors among children who recovered from acute malnutrition (AM) following mid-upper arm circumference (MUAC)-based simplified combined treatment using the ComPAS protocol. A prospective cohort of 420 children who had reached a MUAC ≥ 125 mm for two consecutive measures was monitored between December 2020 and October 2021. Children were seen at home fortnightly for 6 months. The overall 6-month cumulative incidence of relapse [95%CI] into MUAC < 125 mm and/or edema was 26.1% [21.7; 30.8] and 1.7% [0.6; 3.6] to MUAC < 115 mm and/or edema. Relapse was similar among children initially admitted to treatment with a MUAC < 115 mm and/or oedema and among those with a MUAC ≥ 115 mm but <125 mm. Relapse was predicted by lower anthropometry both at admission to and discharge from treatment, and a higher number of illness episodes per month of follow-up. Having a vaccination card, using an improved water source, having agriculture as the main source of income, and increases in caregiver workload during follow-up all protected from relapse. Children discharged as recovered from AM remain at risk of relapsing into AM. To achieve reduction in relapse, recovery criteria may need to be revised and post-discharge strategies tested.

Effectiveness of Dietary Management for Moderate Wasting among Children > 6 Months of Age-A Systematic Review and Meta-Analysis Exploring Different Types, Quantities, and Durations.

Currently, no World Health Organization guidelines exist for the management of approximately 31.8 million moderately wasted children globally. The objective of this review was to synthesise evidence on the optimal type, quantity, and duration of dietary treatment for moderate wasting. Ten electronic databases were searched until the 23rd of August 2021. Experimental studies comparing interventions for the dietary management of moderate wasting were included. Meta-analyses were conducted and results were presented as risk ratios or mean differences with 95% confidence intervals. Seventeen studies comparing specially formulated foods were included involving 23,005 participants. Findings suggest little or no difference in recovery between Fortified Blended Foods (FBFs) with improved micronutrient and/or milk content (enhanced FBFs) and lipid-based nutrient supplements (LNS), whereas children treated with non-enhanced FBFs (locally produced FBFs or standard corn-soy blend) may have lower recovery rates than those treated with LNS. There was no difference in recovery when ready-to-use therapeutic and ready-to-use supplementary food were compared. Other outcomes mostly aligned with results for recovery. In conclusion, LNSs improve recovery compared to non-enhanced FBFs, but are comparable to enhanced FBFs. Programmatic choice of supplement should consider factors such as cost, cost-effectiveness, and acceptability. Further research is required to determine optimal dosing and duration of supplementation.

Current evidence on the effectiveness of Ready-to-Use Supplementary Foods in children with moderate acute malnutrition: a systematic review and meta-analysis.

Moderate acute malnutrition (MAM) is defined by a weight-for-height Z-score (WHZ) between -3 and -2 of the WHO reference or by a mid-upper arm circumference (MUAC) of ≥11⋅5 and <12⋅5 cm. This study aimed to synthesise the evidence for the effectiveness of Ready-to-Use Supplementary Food (RUSF) compared to other dietary interventions or no intervention on functioning at different levels of the International Classification of Functioning, Disability, and Health (ICF) among children with MAM between 2 and12 years old. Three databases (PubMed, Scopus, and Web of Science) were systematically searched (last update: 20 November 2022). Pooled estimates of effect were calculated using random-effects meta-analyses. The level of evidence was estimated with the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) method. Seven studies were included. RUSF had a significant small-sized better effect (pooled mean: 0⋅38; 95 % CI = [0⋅10, 0⋅67], P = 0⋅01, I² = 97 %) on different anthropometric measurements compared to other dietary interventions among MAM children (n 6476). Comparing RUSF with corn-soy blend Plus Plus (CSB++) showed that RUSF had a small-sized but significantly better effect on the children's anthropometric measures compared to children who received CSB++ (pooled mean: 0⋅16; 95 % CI = [0⋅05, 0⋅27], P = 0⋅01; I2 = 35 %). MAM children treated with RUSF had a better recovery rate compared to those treated with CSB++ (pooled risk difference: 0⋅11; 95 % CI = [0⋅06, 0⋅11], P < 0⋅001; I2 = 0 %). The RUSF intervention seems promising in improving MAM children's nutritional outcomes and recovery rate compared to other dietary interventions.

Micronutrient status and energy intake in moderate acute malnourished children after intake of high Energy nutritional supplements for four weeks: a randomized controlled study.

BACKGROUND: Undernutrition including micronutrient deficiency results in adverse health-related outcomes in children of low-medium income countries. This study aims to explore the effect of four weeks of Lipid-based nutritional supplement (LNS) on energy intake, anthropometry and micronutrient status in moderate acute malnourished children. METHODS: Thirty-four children with mean age 7.08±1.47 years and a BMI Z score between -2 and -3 SDS were randomized into LNS and Placebo groups in a single blind randomized control trial. Energy intake, fasting blood samples, and anthropometric measurements were obtained prior to and after four weeks of LNS (535 kcal) or Placebo (92kcal) supplementation in addition to their habitual dietary intake. RESULTS: During four weeks of supplementation, energy intake (kcal) [(611±155) to (987±224), p<0.001)], weight (kg) [(17.5±2.83) to (18.1±3.24), p< 0.001], mid-upper arm circumference (cm) [(14.8±0.91) to (15.1±0.84), p=0.005)] and BMI (kg/m2) [(12.9±0.33) to (13.3±0.45), p=0.002] was significantly improved in the LNS group compared to Placebo. A significant increase in hemoglobin (g/ml) [(12.2±1.14) to (13.7±1.69), p<0.01] and iron levels (µg/dl) [(0.36±0.09) to (0.67±0.20), p<0.001] were observed in the LNS group. No significant differences were detected in the copper and zinc levels. CONCLUSIONS: Lipid-based nutritional supplement is effective in improving energy intake, nutritional outcomes and iron but not copper and zinc. The trial was registered at www.isrctn.com under reference: ISRCTN147181521.

Composite Flour from Indonesian Local Food Resources to Develop Cereal/Tuber Nut/Bean-Based Ready-to-Use Supplementary Foods for Prevention and Rehabilitation of Moderate Acute Malnutrition in Children.

Undernourishment is a threat to human health. The prevalence of undernourishment remains alarming, especially among children under five years old in many countries, including Indonesia. Nowadays, the handling of undernourishment has shifted to treatment outside the hospital, utilizing local nutrient-rich foods. At the national level, the utilization of local food resources is a part of the promotion of dietary diversification and the bioeconomy. Ready-to-use supplementary food (RUSF) refers to supplementary foods aimed at improving the nutrition of moderate acute malnutrition (MAM) children under five years old. RUSF biscuit recipes were made using local food resources available in Banten province, Indonesia. To optimize the nutritional profile of the developed RUSF, taro/talas banten were mixed with ground-nut/peanut (Arachis hypogaea L.) and mungbean (Vigna radiata) as protein and lipid sources and red rice (Oryza longistaminata) and maize (Zea mays) as carbohydrate sources, and enriched by the local banana Nangka (Musa textilia). Two formulations were selected for the pilot testing, namely the taro-peanut and taro-peanut/mungbean RUSF biscuits, made from taro Banten, cereal, peanut and/or mungbean, and local banana. The RUSF biscuit showed promising results, presenting a high level of acceptance and a macronutrient composition that meets the standards for MAM children. However, the RUSF biscuits should be fortified with micronutrient premix to fulfill the dietary requirement for the MAM children. The results of this study provide further development opportunities.

Treating high-risk moderate acute malnutrition using therapeutic food compared with nutrition counseling (Hi-MAM Study): a cluster-randomized controlled trial.

BACKGROUND: There is a lack of consensus on what is the most appropriate treatment of moderate acute malnutrition (MAM). OBJECTIVES: We aimed to determine if provision of ready-to-use-therapeutic food (RUTF) and antibiotics to "high-risk" MAM (HR-MAM) children in addition to nutritional counseling would result in higher recovery and less deterioration than nutrition counseling alone. METHODS: At the 11 intervention clinics, HR-MAM children were given RUTF and amoxicillin along with standard nutrition counseling, for 2-12 wk. All others received 6 wk of nutrition counseling alone. HR-MAM was defined as midupper arm circumference (MUAC) <11.9 cm, weight-for-age z score (WAZ) <-3.5, mother not the main caregiver, or a child <2 y old not being breastfed. Outcomes were compared using intention-to-treat analysis. RESULTS: Analysis included 573 children at the intervention sites and 714 children at the control sites. Of the intervention group, 317 (55%) were classified as HR-MAM. Short-term recovery was greater at the intervention sites [48% compared with 39% at week 12; risk difference (rd): 0.08; 95% CI: 0.03, 0.13]. The intervention group had lower risk of deteriorating to severe acute malnutrition (SAM) (18% compared with 24%; rd: -0.07; 95% CI: -0.11, -0.04), lower risk of dying (1.8% compared with 3.1%; rd: -0.02; 95% CI: -0.03, -0.00), and greater gains in MUAC and weight than did children at the control sites. However, by 24 wk, the risk of SAM was similar between the 2 arms (31% compared with 34%; rd: -0.03; 95% CI: -0.09, 0.02). Control group data identified recent illness, MUAC <12.0 cm, WAZ <-3, dropping anthropometry, age <12 mo, being a twin, and a history of previous SAM as risk factors for deterioration. CONCLUSIONS: Provision of RUTF and antibiotics to HR-MAM children improved short-term recovery and reduced short-term risk of deterioration. However, recovery rates were still suboptimal and differences were not sustained by 6 mo post enrollment.This trial was registered at clinicaltrials.gov as NCT03647150.

Effectiveness and cost-effectiveness of 4 supplementary foods for treating moderate acute malnutrition: results from a cluster-randomized intervention trial in Sierra Leone.

BACKGROUND: Moderate acute malnutrition (MAM) affects 33 million children annually. Investments in formulations of corn-soy blended flours and lipid-based nutrient supplements have effectively improved MAM recovery rates. Information costs and cost-effectiveness differences are still needed. OBJECTIVES: We assessed recovery and sustained recovery rates of MAM children receiving a supplementary food: ready-to-use supplementary food (RUSF), corn soy whey blend with fortified vegetable oil (CSWB w/oil), or Super Cereal Plus with amylase (SC + A) compared to Corn Soy Blend Plus with fortified vegetable oil (CSB+ w/oil). We also estimated differences in costs and cost effectiveness of each supplement. METHODS: In Sierra Leone, we randomly assigned 29 health centers to provide a supplement containing 550 kcal/d for ∼12 wk to 2691 children with MAM aged 6-59 mo. We calculated cost per enrollee, cost per child who recovered, and cost per child who sustained recovery each from 2 perspectives: program perspective and caregiver perspective, combined. RESULTS: Of 2653 MAM children (98.6%) with complete data, 1676 children (63%) recovered. There were no significant differences in the odds of recovery compared to CSB+ w/oil [0.83 (95% CI: 0.64-1.08) for CSWB w/oil, 1.01 (95% CI: 0.78-1.3) for SC + A, 1.05 (95% CI: 0.82-1.34) for RUSF]. The odds of sustaining recovery were significantly lower for RUSF (0.7; 95% CI 0.49-0.99) but not CSWB w/oil or SC + A [1.08 (95% CI: 0.73-1.6) and 0.96 (95% CI: 0.67-1.4), respectively] when compared to CSB+ w/oil. Costs per enrollee [US dollars (USD)/child] ranged from $105/child in RUSF to $112/child in SC + A and costs per recovered child (USD/child) ranged from $163/child in RUSF to $179/child in CSWB w/oil, with overlapping uncertainty ranges. Costs were highest per sustained recovery (USD/child), ranging from $214/child with the CSB+ w/oil to $226/child with the SC + A, with overlapping uncertainty ranges. CONCLUSIONS: The 4 supplements performed similarly across recovery (but not sustained recovery) and costed measures. Analyses of posttreatment outcomes are necessary to estimate the full cost of MAM treatment. This trial was registered at clinicaltrials.gov as NCT03146897.

Body Composition Changes in Children during Treatment for Moderate Acute Malnutrition: Findings from a 4-Arm Cluster-Randomized Trial in Sierra Leone.

BACKGROUND: Measures that better describe "healthy" and sustainable recovery during nutritional treatment of children with moderate acute malnutrition (MAM) are needed. OBJECTIVES: We compared changes to body composition among children receiving 1 of 4 specialized nutritious food (SNFs) during treatment of MAM and by recovery and relapse outcomes. METHODS: The study was nested within a prospective, cluster-randomized, community-based, cost-effectiveness trial assessing 4 SNFs to treat children aged 6-59 mo with MAM [midupper arm circumference (MUAC) ≥11.5 cm and <12.5 cm without bipedal edema] in Sierra Leone. Biweekly SNF rations (1 of 3 fortified-blended foods or a lipid-based nutrient supplement) were given until children recovered (MUAC ≥12.5 cm), or up to 7 rations (∼12 wk). Deuterium dilution was used to estimate fat-free mass (FFM) and fat mass (FM) at enrollment and after 4 wk of treatment to ensure similar treatment exposure among the participants. Another MUAC measurement was performed among recovered children 4 wk after program exit to determine whether recovery was sustained. ANOVA, paired t tests, and linear regression models were used to determine significant differences in changes from baseline to 4 wk. RESULTS: Among 312 analyzed participants, mean baseline weight comprised ∼80% FFM; mean weight gained after 4 wk comprised ∼82% FFM. Changes in FM and FFM among 4 SNFs were similar. Children who recovered gained more weight (241%), FFM (179%), and weight-for-height z score (0.44 compared with 0) compared with those who did not recover; sustainers gained 150% more weight. FM gains were positive among recovered children and sustainers, as well as negative among those who did not recover or sustain recovery, but not significantly different. CONCLUSIONS: Four SNFs had similar effects on body composition in children after 4 wk of treatment for MAM, showing a healthy pattern of weight gain, the majority being FFM. Differential responses to treatment underscore a need for further research to provide targets for healthy, sustainable recovery. This trial was registered at clinicaltrials.gov as NCT03146897.

Effect of a ready-to-use supplementary food on the recovery of preschool children with malnutrition.

INTRODUCTION: In developing countries, protein-energy malnutrition causes 60% of deaths in children < 5 years of age. OBJECTIVE: To evaluate the effect of a ready-to-use supplementary food (RUSF) on moderate acute malnutrition (MAM) in preschool children. METHOD: Clinical trial that included 155 children with MAM (weight/height Z-score > -3 and ≤ -2). Each child received RUSF in the form of biscuits, four per day (250 kcal), for 12 months. The tutor received education on nutrition, health and hygiene. Recovery (weight/height Z-score > -2) at four, six, and 12 months was assessed using intent-to-treat (ITT) and per protocol (PP) analyses. Changes in chronic malnutrition were also analyzed. RESULTS: In the first semester, adequate RUSF consumption was observed in 61% of the children, and in 42% in the second semester. In the ITT analysis, 78% were identified to have recovered, with 38% reaching normal nutritional values; in the PP analysis, > 90% recovered and > 40% reached normal values. Recovery from chronic malnutrition was also observed. CONCLUSIONS: The consumption of RUSF and an educational program reduced MAM.

INTRODUCCIÓN: En países en desarrollo, la desnutrición proteico-energética causa 60 % de las muertes en los niños menores de cinco años. OBJETIVO: Evaluar el efecto de un suplemento alimenticio listo para consumir (SALC) en la desnutrición aguda moderada (DAM) en niños preescolares. MÉTODO: Ensayo clínico que incluyó 155 niños con DAM (puntuación Z de peso/talla [pZ] mayor de −3 y menor o igual a −2). Cada niño recibió SALC en forma de galletas, cuatro por día (250 kcal), durante 12 meses. El tutor recibió educación sobre nutrición, salud e higiene. La recuperación (pZ peso/talla mayor de −2) a los cuatro, seis y 12 meses se evaluó con un análisis por intención a tratar (AIT) y por protocolo (APP). También se analizaron cambios en la desnutrición crónica. RESULTADOS: En el primer semestre se observó consumo adecuado del SALC en 61 % de los niños y en 42 % en el segundo semestre. Con el AIT se identificó que 78 % se recuperó y 38 % alcanzó valores normales de nutrición; con el APP, > 90 % se recuperó y > 40 % alcanzó valores normales. Se observó recuperación de la desnutrición crónica. CONCLUSIONES: El consumo de SALC y un programa educativo redujeron la DAM.

Development and nutritional evaluation of local ingredients-based supplements to treat moderate acute malnutrition among children aged below five years: A descriptive study from rural Wolaita, Southern Ethiopia.

In Ethiopia, moderate acute malnutrition (MAM) is a persistent public health problem. The current management approaches for MAM among children are counseling in food-secure settings and food supplementation in chronically food-insecure areas. The objective of this study was to develop a local ingredients-based supplement (LIBS) for treating MAM among children. Collection of food ingredients (pumpkin seed, amaranth grain, flaxseed, peanut, and emmer wheat) was made. Sorting, soaking, drying, roasting, and milling of ingredients were done. Nutrient analysis was done using triplicate measurements of each nutrient. One-way ANOVA was used to analyze differences in means with ± standard deviation of nutrient measurements among the supplements. The nutrient content of four developed LIBS ranged from 20.3 g to 22.5 g for protein, 29.3 g to 33.5 g for fat, 509.5 kcal to 570.0 for kcal, 6.0 g to 8.5 g for fiber, 2.8 g to 3.7 g for moisture, and 2.1 g to 4.3 g for ash. The mineral and antinutrient components ranged from 75.6 mg to 115.6 mg for calcium, 473.1 mg to 570.2 mg for potassium, 79.3 mg to 114.4 mg for sodium, 4.1 mg to 5.6 mg for zinc, 8.2 mg to 10.2 mg for iron, 442.6 mg to 470.4 mg for phosphorous, and 2.1 mg to 4.3 mg for phytate. The LIBS with the highest portion of pumpkin seed had significantly highest amounts of protein, fat, calories, iron, zinc, and potassium. The results found were within the recommended range of required nutrients for the treatment of children with MAM. Therefore, LIBS may be used for the management of children with MAM.

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.

Systematic review of the treatment of moderate acute malnutrition using food products.

There is currently a lack of international guidance on the most appropriate treatment for moderate acute malnutrition (MAM), and discrepancies in national treatment guidelines exist. We aimed to explore whether food interventions are effective for MAM children 6-59 months old and whether they result in better outcomes compared with no treatment or management with nutrition counselling. A systematic literature search was conducted in October 2018, identifying studies that compared treating MAM children with food products versus management with counselling or no intervention. A total of 673 abstracts were screened, 101 full texts were read, and one study was identified that met our inclusion criteria. After broadening the criteria to include micronutrients in the control group and enrolment based on out-dated anthropometric criteria, 11 studies were identified for inclusion. Seven of these found food products to be superior for anthropometric outcomes compared with counselling and/or micronutrient supplementation; two of the studies found no significant benefit of a food product intervention; and two studies were inconclusive. Hence, the majority of studies in this review found that food products resulted in greater anthropometric gains than counselling or micronutrient interventions. This was especially true if the supplementary food provided was of suitable quality and provided for an adequate duration. Improving quality of and adherence to counselling may improve its effectiveness, particularly in food secure contexts. There is currently a paucity of comparable studies on this topic as well as a lack of studies that include important functional outcomes beyond anthropometric proxies.

Research protocol local ingredients-based supplementary food as an alternative to corn-soya blends plus for treating moderate acute malnutrition among children aged 6 to 59 months: a randomized controlled non-inferiority trial in Wolaita.

BACKGROUND: In Ethiopia, 12.5% of children below 5 years are wasted, and 9.7% are moderately wasted. The present strategy for the management of moderate acute malnutrition (MAM) is a supplementary feeding program; however, this is only provided to chronically food-insecure areas. This randomized controlled non-inferiority trial examines if Local ingredients-based supplement (LIBS) is as effective as corn-soya blends plus (CSB+) in treating moderate acute malnutrition among children aged 6-59 months. METHODS: A randomized controlled non-inferiority trial will be conducted with moderately wasted children aged 6 to 59 months in Wolaita, Ethiopia. The calculated sample size is 324 (i.e. with 162 children in each of two arms, to be assigned by randomization). The daily ration will be: 100 g of LIBS plus 25.2 g of sugar with 8 ml oil in the intervention group, and 150 g of CSB+ with 16 ml of oil in the control group. These interventions will be provided for a maximum period of 12 weeks, with follow-up performed on a weekly basis. Data analysis will be done using SPSS and STATA software. Both intention-to-treat and per protocol analyses will be done. Hazard ratio and Kaplan-Meier (log rank) curves of survival analysis will be done to predict the probability of recovery rate. Logistic regression will be used to test for interactions between independent and dependent variables. Analysis of variances, t-tests, fisher's exact test and chi-square tests will be used to assess baseline characteristics. CONCLUSIONS: This paper will introduce to the existing research locally available nutritious foods which have the potential to enhance recovery from moderate acute malnutrition and to reduce the burden of malnutrition. The perceptions of mothers on feeding children with local ingredient-based supplementary food to assist recovery from moderate acute malnutrition will be the focus of in a qualitative study to follow; this will provide a further contribution in an evolving area of research. TRIAL REGISTRATION: Pan-African Clinical Trial Registration number: PACTR201809662822990, retrospectively registered on 11/09/2018.

Cost-effectiveness of community-based screening and treatment of moderate acute malnutrition in Mali.

INTRODUCTION: Moderate acute malnutrition (MAM) causes substantial child morbidity and mortality, accounting for 4.4% of deaths and 6.0% of disability-adjusted life years (DALY) lost among children under 5 each year. There is growing consensus on the need to provide appropriate treatment of MAM, both to reduce associated morbidity and mortality and to halt its progression to severe acute malnutrition. We estimated health outcomes, costs and cost-effectiveness of four dietary supplements for MAM treatment in children 6-35 months of age in Mali. METHODS: We conducted a cluster-randomised MAM treatment trial to describe nutritional outcomes of four dietary supplements for the management of MAM: ready-to-use supplementary foods (RUSF; PlumpySup); a specially formulated corn-soy blend (CSB) containing dehulled soybean flour, maize flour, dried skimmed milk, soy oil and a micronutrient pre-mix (CSB++; Super Cereal Plus); Misola, a locally produced, micronutrient-fortified, cereal-legume blend (MI); and locally milled flour (LMF), a mixture of millet, beans, oil and sugar, with a separate micronutrient powder. We used a decision tree model to estimate long-term outcomes and calculated incremental cost-effectiveness ratios (ICERs) comparing the health and economic outcomes of each strategy. RESULTS: Compared to no MAM treatment, MAM treatment with RUSF, CSB++, MI and LMF reduced the risk of death by 15.4%, 12.7%, 11.9% and 10.3%, respectively. The ICER was US$9821 per death averted (2015 USD) and US$347 per DALY averted for RUSF compared with no MAM treatment. CONCLUSION: MAM treatment with RUSF is cost-effective across a wide range of willingness-to-pay thresholds. TRIAL REGISTRATION: NCT01015950.

Effect of a novel supplementary porridge on the nutritional status of infants and young children diagnosed with moderate acute malnutrition in Uganda: a cluster randomised control trial.

BACKGROUND: Moderate acute malnutrition (MAM) and anaemia are prevalent among infants and young children (IYC) in Uganda. A lack of consensus regarding the most effective strategy for managing MAM among IYC resulted in the present study comparing the effect of malted sorghum-based porridge (MSBP) (an active malt, extruded maize and soy sorghum supplementary porridge developed for the purpose of the present study) as an intervention versus an extruded maize and soy micronutrient fortified blend (CSB+) as a control and current standard care. Outcome measures were anthropometric status and haemoglobin levels. METHODS: The study comprised a double-blind cluster randomised control trial with eight to 10 conveniently sampled consenting mother-IYC pairs per cluster who were randomly assigned to the intervention (n = 110) or control (n = 110) for 3 months. Weekly anthropometric measurements were taken. Haemoglobin levels were measured at baseline and end line. Mean length-for-age, weight-for-age, length-for-weight and mean haemoglobin levels of the treatment and control groups were compared using an independent t-test. The Z-test was used to compare proportions of the outcome indicators between the treatment and control groups. RESULTS: Difference in mean weight-for-age Z-scores in the treatment group improved compared to control (P = 0.010). The change in mean haemoglobin levels was lower in the treatment versus the control group (P = 0.010). The proportion of IYC recovering from MAM between treatment and control did not differ significantly (P = 0.055). CONCLUSIONS: Recovery rates after supplementation with MSBP versus CSB+ resulted in similar weight-for-length and haemoglobin levels. Therefore, MSBP has the potential for being scaled up in the management of IYC with MAM in Uganda.

Maximizing Recovery and Growth When Treating Moderate Acute Malnutrition with Whey-Containing Supplements.

BACKGROUND: Much debate exists about the utility of dairy ingredients in the supplementary foods used to treat childhood moderate acute malnutrition (MAM). OBJECTIVE: To review the evidence regarding the effectiveness of dairy-containing supplements, particularly specially formulated foods containing whey permeate and whey protein concentrate, in treating children with MAM. METHODS: A summary of a conference presentation regarding an overview of current evidence behind the use of whey in supplementary foods, including results of a randomized double-blinded clinical effectiveness trial involving 2259 Malawian children treated for MAM using either a soy ready-to-use supplementary food (RUSF) or a novel whey RUSF treatment. RESULTS: While the majority of the evidence base only suggests potential benefits of including whey in supplementary foods to treat MAM, a recent study specifically demonstrates that a whey RUSF produced superior recovery and growth outcomes in treating children with MAM when compared with a soy RUSF. CONCLUSIONS: The use of whey ingredients has been shown to improve outcomes in the treatment of MAM; however, further research is needed to identify the ideal amount and type of dairy protein required to produce the best outcomes for the lowest cost.

Higher Levels of Dairy Result in Improved Physical Outcomes: A Synthesis of 3 Randomized Controlled Trials in Guinea-Bissau Comparing Supplements with Different Levels of Dairy Ingredients Among Children 6 to 59 Months, 5 to 19 Year Olds, and Mothers in Preschools, Primary Schools, and Villages, and the Implications for Programs.

BACKGROUND: This article synthesizes the results of 3 cluster randomized controlled trials of dairy-containing ready-to-use supplementary foods (RUSFs) to address malnutrition in primary schools, preschools and villages in Guinea-Bissau, one of the world's poorest countries. Together, these studies document widespread malnutrition across infants, young children, adolescents, and pregnant and lactating women and point to intervention options that were not previously presented. OBJECTIVE: To combine the evidence from the United States Department of Agriculture-funded pilot studies in Guinea-Bissau on the effects of dairy protein supplementation to gain a broader perspective on the role of dairy containing RUSFs in various age-groups, the importance of the mother-child dyad and family food dynamics for infant and child growth. Translate the results into action and the next generation of effective products. METHODS: A comparative analysis of data and synthesis of evidence from 3 published studies and ongoing research conducted by our team in Guinea-Bissau. RESULTS AND CONCLUSIONS: Higher dairy supplements have the potential to achieve broad benefits for malnutrition, especially in mothers and early childhood (first 1000 days and 36-59 months). Higher levels of dairy protein also can prevent moderate acute malnutrition in children younger than 2 years, independent of the family food dynamic. Community-level nutrition behavior change education should target older children and adolescents at the community level and through the preschool/school platform.