evidence-based blog of Filippo Dibari

Posts Tagged ‘RCT’

Preventing Acute Malnutrition among Young Children in Crises: A Prospective Intervention Study in Niger

In Under-nutrition on September 15, 2014 at 11:14 am

Céline Langendorf, Thomas Roederer, Saskia de Pee, Denise Brown, Stéphane Doyon, Abdoul-Aziz Mamaty, Lynda W.-M. Touré, Mahamane L. Manzo, Rebecca F. Grais

PLoS Med. 2014 Sep 2;11(9):e1001714



Finding the most appropriate strategy for the prevention of moderate acute malnutrition (MAM) and severe acute malnutrition (SAM) in young children is essential in countries like Niger with annual “hunger gaps.” Options for large-scale prevention include distribution of supplementary foods, such as fortified-blended foods or lipid-based nutrient supplements (LNSs) with or without household support (cash or food transfer). To date, there has been no direct controlled comparison between these strategies leading to debate concerning their effectiveness. We compared the effectiveness of seven preventive strategies—including distribution of nutritious supplementary foods, with or without additional household support (family food ration or cash transfer), and cash transfer only—on the incidence of SAM and MAM among children aged 6–23 months over a 5-month period, partly overlapping the hunger gap, in Maradi region, Niger. We hypothesized that distributions of supplementary foods would more effectively reduce the incidence of acute malnutrition than distributions of household support by cash transfer.

Methods and Findings

We conducted a prospective intervention study in 48 rural villages located within 15 km of a health center supported by Forum Santé Niger (FORSANI)/Médecins Sans Frontières in Madarounfa. Seven groups of villages (five to 11 villages) were allocated to different strategies of monthly distributions targeting households including at least one child measuring 60 cm–80 cm (at any time during the study period whatever their nutritional status): three groups received high-quantity LNS (HQ-LNS) or medium-quantity LNS (MQ-LNS) or Super Cereal Plus (SC+) with cash (€38/month [US$52/month]); one group received SC+ and family food ration; two groups received HQ-LNS or SC+ only; one group received cash only (€43/month [US$59/month]). Children 60 cm–80 cm of participating households were assessed at each monthly distribution from August to December 2011. Primary endpoints were SAM (weight-for-length Z-score [WLZ]<−3 and/or mid-upper arm circumference [MUAC]<11.5 cm and/or bipedal edema) and MAM (−3≤WLZ<−2 and/or 11.5≤MUAC<12.5 cm). A total of 5,395 children were included in the analysis (615 to 1,054 per group). Incidence of MAM was twice lower in the strategies receiving a food supplement combined with cash compared with the cash-only strategy (cash versus HQ-LNS/cash adjusted hazard ratio [HR] = 2.30, 95% CI 1.60–3.29; cash versus SC+/cash HR = 2.42, 95% CI 1.39–4.21; cash versus MQ-LNS/cash HR = 2.07, 95% CI 1.52–2.83) or with the supplementary food only groups (HQ-LNS versus HQ-LNS/cash HR = 1.84, 95% CI 1.35–2.51; SC+ versus SC+/cash HR = 2.53, 95% CI 1.47–4.35). In addition, the incidence of SAM was three times lower in the SC+/cash group compared with the SC+ only group (SC+ only versus SC+/cash HR = 3.13, 95% CI 1.65–5.94). However, non-quantified differences between groups, may limit the interpretation of the impact of the strategies.


Preventive distributions combining a supplementary food and cash transfer had a better preventive effect on MAM and SAM than strategies relying on cash transfer or supplementary food alone. As a result, distribution of nutritious supplementary foods to young children in conjunction with household support should remain a pillar of emergency nutritional interventions. Additional rigorous research is vital to evaluate the effectiveness of these and other nutritional interventions in diverse settings.

Trial registration

ClinicalTrials.gov NCT01828814


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A Lipid-Based Nutrient Supplement but Not Corn-Soy Blend Modestly Increases Weight Gain among 6- to 18-Month-Old Moderately Underweight Children in Rural Malawi

In Under-nutrition on April 19, 2014 at 9:07 am

by Thakwalakwa C, Ashorn P, Phuka J, Cheung YB, Briend A, Puumalainen T, Maleta K.

J. Nutr. November 1, 2010 vol. 140 no. 11 2008-2013



Although widely used, there is little information concerning the efficacy of corn-soy blend (CSB) supplementation in the treatment of moderate underweight in African children. Lipid-based nutrient supplements (LNS), which have proven to be beneficial treatment for severely wasted children, could offer benefits to less severely affected individuals.

We conducted a clinical randomized trial to determine whether LNS or CSB supplementation improves weight gain of moderately underweight children. A total of 182 underweight [weight-for-age Z-score (WAZ) < −2] 6- to 15-mo-old children were randomized to receive for 12 wk a ration of 43 g/d LNS or 71 g/d CSB, providing 1189 and 921 kJ, respectively, or no supplementation (control). The primary outcome was weight change; secondary outcomes included changes in anthropometric indices, hemoglobin levels, and morbidity.

The body weight increases (mean ± SD) did not differ and were 620 ± 470, 510 ± 350, and 470 ± 350 g in the LNS, CSB, and control groups, respectively (P = 0.11). Compared with controls, infants and children in the LNS group gained more weight [mean (95% CI) = 150 g (0–300 g); P = 0.05] and had a greater increase in WAZ [0.33 (−0.02–0.65); P = 0.04]. Weight and WAZ changes did not differ between the control and CSB groups. In exploratory stratified analysis, the weight increase was higher in the LNS group compared with the control group among those with lower initial WAZ [250 g (60–430 g; P = 0.01].

Supplementation with LNS but not CSB modestly increases weight gain among moderately underweight children and the effect appears most pronounced among those with a lower initial WAZ.



Effect of Supplementation with a Lipid-Based Nutrient Supplement on the Micronutrient Status of Children Aged 6-18 Months Living in the Rural Region of Intibucá, Honduras.

In Under-nutrition on March 26, 2014 at 4:35 pm

Siega-Riz AM1, Estrada Del Campo Y, Kinlaw A, Reinhart GA, Allen LH, Shahab-Ferdows S, Heck J, Suchindran CM, Bentley ME.

Paediatr Perinat Epidemiol. 2014 Mar 13





Lipid-based nutrient supplements (LNS) have been effective in the treatment of acute malnutrition among children. We evaluated the use of LNS supplementation for improving the micronutrient status of young children.


A 12-month randomised controlled trial was conducted among children aged 6-18 months living in Intibucá, Honduras. Communities (n = 18) were randomised into clusters matched by poverty indicators (9 intervention, n = 160 and 9 controls, n = 140). Intervention participants received LNS. All children received food vouchers and nutrition education. Primary outcomes included measures of micronutrient status: at baseline, 6 and 12 months’ blood were collected for assessment of folate, iron, zinc, riboflavin, and vitamin B12 status; haemoglobin was measured every 3 months; and dietary and anthropometry collected monthly. Longitudinal analyses were based on intent to treat and LNS adherence. Generalised estimating equations were used in the estimation of generalised linear regression models specified for the data.


At 6-month follow-up, children in the intervention group had a lower proportion classified as deficient for B12 (43.6%) compared with the control (67.7%; P = 0.03). The intervention group had a higher mean concentration for folate at 6 months (P = 0.06), and improvements continued through 12 months for folate (P = 0.002) and vitamin A deficiency (P = 0.03). This pattern of results, with improved significance, remained in subanalysis based on LNS adherence.


These data demonstrate that LNS improved select micronutrient status in young non-malnourished Honduran children.

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Comparison of the effectiveness of a milk-free soy-maize-sorghum-based ready-to-use therapeutic food to standard ready-to-use therapeutic food with 25% milk in nutrition management of severely acutely malnourished Zambian children: an equivalence non-blinded cluster randomised controlled trial

In Under-nutrition on July 7, 2013 at 12:33 pm

by Irena AH, Bahwere P, Owino VO, Diop EI, Bachmann MO, Mbwili-Muleya C, Dibari F, Sadler K, Collins S.

Matern Child Nutr. 2013 Jun 18.


Community-based Management of Acute Malnutrition using ready-to-use therapeutic food (RUTF) has revolutionised the treatment of severe acute malnutrition (SAM). However, 25% milk content in standard peanut-based RUTF (P-RUTF) makes it too expensive. The effectiveness of milk-free RUTF has not been reported hitherto.

This non-blinded, parallel group, cluster randomised, controlled, equivalence trial that compares the effectiveness of a milk-free soy-maize-sorghum-based RUTF (SMS-RUTF) with P-RUTF in treatment of children with SAM, closes the gap. A statistician randomly assigned health centres (HC) either to the SMS-RUTF (n = 12; 824 enrolled) or P-RUTF (n = 12; 1103 enrolled) arms. All SAM children admitted at the participating HCs were enrolled. All the outcomes were measured at individual level. Recovery rate was the primary outcome.

The recovery rates for SMS-RUTF and P-RUTF were 53.3% and 60.8% for the intention-to-treat (ITT) analysis and 77.9% and 81.8% for per protocol (PP) analyses, respectively. The corresponding adjusted risk difference (ARD) and 95% confidence interval, were -7.6% (-14.9, 0.6%) and -3.5% (-9,6., 2.7%) for ITT (P = 0.034) and PP analyses (P = 0.257), respectively. An unanticipated interaction (interaction P < 0.001 for ITT analyses and 0.0683 for PP analyses) between the study arm and age group was observed. The ARDs were -10.0 (-17.7 to -2.3)% for ITT (P = 0.013) and -4.7 (-10.0 to 0.7) for PP (P = 0.083) analyses for the <24 months age group and 2.1 (-10.3,14.6)% for ITT (P = 0.726) and -0.6 (-16.1, 14.5) for PP (P = 0.939) for the ≥24 months age group.

In conclusion, the study did not confirm our hypothesis of equivalence between SMS-RUTF and P-RUTF in SAM management.

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Children successfully treated for moderate acute malnutrition remain at risk for malnutrition and death in the subsequent year after recovery

In Under-nutrition on February 27, 2013 at 7:50 pm

J Nutr. 2013 Feb;143(2):215-20. doi: 10.3945/jn.112.168047. Epub 2012 Dec 19.

by Chang CYTrehan IWang RJThakwalakwa CMaleta KDeitchler MManary MJ.


Moderate acute malnutrition (MAM) affects 11% of children <5 y old worldwide and increases their risk for morbidity and mortality. It is assumed that successful treatment of MAM reduces these risks.

A total of 1967 children aged 6-59 mo successfully treated for MAM in rural Malawi following randomized treatment with corn-soy blend plus milk  and oil (CSB++), soy ready-to-use supplementary food (RUSF), or soy/whey RUSF were followed for 12 mo. The initial supplementary food was given until the child reached a weight-for-height Z-score (WHZ) >-2. The median duration of feeding was 2 wk, with a maximum of 12 wk.

The hypothesis tested was that children treated with either RUSF would be more likely to remain well-nourished than those treated with CSB++.The primary outcome, remaining well-nourished, was defined as mid-upper arm circumference ≥12.5 cm or WHZ ≥-2 for the entire duration of follow-up.

During the 12-mo follow-up period, only 1230 (63%) children remained well-nourished, 334 (17%) relapsed to MAM, 190 (10%) developed severe acute malnutrition, 74 (4%) died, and 139 (7%) were lost to follow-up.

Children who were treated with soy/whey RUSF were more likely to remain well-nourished (67%) than those treated with CSB++ (62%) or soy RUSF (59%) (P = 0.01).

A seasonal pattern of food insecurity and adverse clinical outcomes was observed. This study demonstrates that children successfully treated for MAM with soy/whey RUSF are more likely to remain well-nourished; however, all children successfully treated for MAM remain vulnerable.


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Development of a crossover-randomized trial method to determine the acceptability and safety of novel ready-to-use therapeutic foods (ahead of print)

In Under-nutrition on September 19, 2012 at 5:07 pm

by Dibari F, Bahwere P, Huerga H, Irena AH, Owino V, Collins S, Seal A.

Nutrition (article in press).


Objective: To develop a method for determining the acceptability and safety of ready-to-use therapeutic foods (RUTF) before clinical trialing. Acceptability was defined using a combination of three consumption, nine safety, and six preference criteria. These were used to compare a soy/maize/sorghum RUTF (SMS-RUTFh), designed for the rehabilitation of human immunodeficiency virus/tuberculosis (HIV/TB) wasted adults, with a peanut-butter/milk-powder paste (P-RUTF; brand: Plumpy’nut) designed for pediatric treatment.

Methods: A cross-over, randomized, controlled trial was conducted in Kenya. Ten days of repeated measures of product intake by 41 HIV/TB patients, >18 y old, body mass index (BMI) 18-24 kg/m^2, 250 g were offered daily under direct observation as a replacement lunch meal. Consumption, comorbidity, and preferences were recorded.

Results: The study arms had similar age, sex, marital status, initial BMI, and middle upper-arm circumference. No carryover effect or serious adverse events were found. SMS-RUTFh energy intake was not statistically different from the control, when adjusted for BMI on day 1, and the presence of throat sores. General preference, taste, and sweetness scores were higher for SMS-RUTFh compared to the control (P < 0.05). Most consumption, safety, and preference criteria for SMS-RUTFh were satisfied except for the average number of days of nausea (0.16 versus 0.09 d) and vomiting (0.04 versus 0.02 d), which occurred with a higher frequency (P < 0.05).

Conclusion: SMS-RUTFh appears to be acceptable and can be safely clinically trialed, if close monitoring of vomiting and nausea is included. The method reported here is a useful and feasible approach for testing the acceptability of ready-to-use foods in low income countries.

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Maternal Multiple Micronutrient Supplements and Child Cognition: A Randomized Trial in Indonesia

In Under-nutrition on September 1, 2012 at 7:20 am

Elizabeth L. PradoKatherine J. AlcockHusni MuadzMichael T. UllmanAnuraj H. Shankar, for the SUMMIT Study Group

Pediatrics. August 20, 2012


OBJECTIVES: We investigated the relative benefit of maternal multiple micronutrient (MMN) supplementation during pregnancy and until 3 months postpartum compared with iron/folic acid supplementation on child development at preschool age (42 months).

METHODS: We assessed 487 children of mothers who participated in the Supplementation with Multiple Micronutrients Intervention Trial, a cluster-randomized trial in Indonesia, on tests adapted and validated in the local context measuring motor, language, visual attention/spatial, executive, and socioemotional abilities. Analysis was according to intention to treat.

RESULTS: In children of undernourished mothers (mid-upper arm circumference <23.5 cm), a significant benefit of MMNs was observed on motor ability (B = 0.39 [95% confidence interval (CI): 0.08–0.70]; P = .015) and visual attention/spatial ability (B = 0.37 [95% CI: 0.11–0.62]; P = .004). In children of anemic mothers (hemoglobin concentration <110 g/L), a significant benefit of MMNs on visual attention/spatial ability (B = 0.24 [95% CI: 0.02–0.46]; P = .030) was also observed. No robust effects of maternal MMN supplementation were found in any developmental domain over all children.

CONCLUSIONS: When pregnant women are undernourished or anemic, provision of MMN supplements can improve the motor and cognitive abilities of their children up to 3.5 years later, particularly for both motor function and visual attention/spatial ability. Maternal MMN but not iron/folic acid supplementation protected children from the detrimental effects of maternal undernutrition on child motor and cognitive development.

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An effectiveness trial showed lipid-based nutrient supplementation but not corn–soya blend offered a modest benefit in weight gain among 6- to 18-month-old underweight children in rural Malawi

In Under-nutrition on August 28, 2012 at 8:44 pm

by Chrissie M Thakwalakwa, Per Ashorn, Mpumulo Jawati, John C Phuka, Yin Bun Cheung and Kenneth M Maleta

Public Health Nutrition / Volume 15 / Issue 09 / September 2012 , pp 1755-1762


 Objective To determine if supplementation with corn–soya blend (CSB) or lipid-based nutrient supplement (LNS) improved the weight gain of moderately underweight infants and children when provided through the national health service.

Design A randomised, controlled, assessor-blinded clinical trial. Infants and children were randomised to receive for 12 weeks an average daily ration of 71 g CSB or 43 g LNS, providing 1188 kJ and 920 kJ, respectively, or no supplement (control). Main outcome was weight gain. Secondary outcomes included changes in anthropometric indices and incidence of serious adverse events. Intention-to-treat analyses were used.

Setting Kukalanga, Koche, Katema and Jalasi health centres in Mangochi District, rural Malawi.

Subjects Underweight (weight-for-age Z-score <−2) infants and children aged 6–15 months (n 299).

Results Mean weight gain was 630 g, 680 g and 750 g in control, CSB and LNS groups, respectively (P = 0·21). When adjusted for baseline age, children receiving LNS gained on average 90 g more weight (P = 0·185) and their weight-for-length Z-score increased 0·22 more (P = 0·049) compared with those receiving no supplementation. No statistically significant differences were observed between the CSB and control groups in mean weight and length gain.

Conclusions LNS supplementation provided during the lean season via through the national health service was associated with a modest increase in weight. However, the effect size was lower than that previously reported under more controlled research settings.

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The effect of an integrated multisector model for achieving the Millennium Development Goals and improving child survival in rural sub-Saharan Africa: a non-randomised controlled assessment

In Under-nutrition on August 13, 2012 at 1:15 pm

Pronyk PM, Muniz M, Nemser B et al. – The Lancet 379: 2179-88; 2012

In the year 2000, world leaders committed their nations to achieving the Millennium Development Goals (MDGs), by establishing a new global partnership to reduce extreme poverty and address a series of related health and development issues. One of the MDGs is to reduce child mortality by two-thirds between 1990 and 2015. The Millennium Villages Project (MVP) was designed as a 10-year initiative to support the integrated delivery of a package of scientifically proven interventions.  The primary aim of the MVP is to accomplish MDGs across a diverse set of rural, sub-Saharan African sites. Local partnerships were forged among the MVP staff members, representatives of local communities, and government personnel to coordinate activities across multiple sectors, including health, agriculture, the environment, education, business and infrastructure development. The aim of the paper reviewed in this month’s edition of NNA was to assess the effects of the project on MDG-related outcomes, including child mortality, 3 years after its implementation.

The Millennium Village sites were chosen to represent a broad range of agro-ecological conditions in nine sub-Saharan African countries. The average population size of the rural intervention villages was ~35,000 residents, who were characterized by high levels of poverty and undernutrition. Starting in 2006, simultaneous investments were made in the aforementioned sectors at a planned total annual cost of 120 USD per person. In agriculture, interventions were designed to increase crop yields and enhance food security by promoting subsidized fertilizers and improved seeds for major staple crops. Additional efforts to improve nutrition via agriculture included support for cultivation of nutritious crops in home gardens, fish farming, and livestock and small animal rearing (1). Direct nutrition interventions included child-growth monitoring, vitamin A supplementation and treatment of acute malnutrition. Community-health workers were also trained to promote exclusive breastfeeding for the first 6 months of life and encourage locally appropriate complementary foods and continued breast feeding thereafter (1). Nutrition-related efforts also focused on improving maternal access to prenatal care, including iron and folic acid supplementation. All interventions were adapted and flexibly implemented in response to local conditions after consultations with government leaders and local community representatives (2).

The current MVP assessment included measurement of selected MDG-related outcomes before and 3 years after the intervention was initiated. Both sets of assessments were conducted during pre-harvest periods. Local comparison village sites were identified for the follow-up assessment to enhance the plausibility that any recorded changes in the intervention villages were due to exposure to the interventions. The comparison sites were randomly selected from up to three candidate villages matched on community-level parameters that were deemed to be possibly associated with the child mortality and other MDG outcomes. Efforts were made to ensure adequate distance between Millennium Village sites and comparison sites to minimize spillover effects (average distance 40 km). At each assessment round a household survey was completed to gather information on demographic characteristics, education, employment assets, land ownership, agricultural practices, food security, bednet usage, and access to basic services including water, sanitation, energy, transport, and communication. An additional questionnaire was administered to an adult aged 15-49 years to examine health-related MDGs, nutrition and common causes of child mortality. Blood smears were collected to assess malaria parasitemia, and anthropometric assessments were done for children younger than 5 years of age.

Results and conclusions
Spending levels on MDG-related activities by governments, non-governmental organizations, and the communities were estimated to be 27 USD per person at baseline.  Average annual spending in the third year of the project increased to about 116 USD per person, of which 25 USD was spent on health. After 3 years of intervention, reductions were reported in poverty, food insecurity, stunting prevalence and malaria parasitemia across the nine Millennium Village sites.  No changes were reported in access to antenatal care or prevalence of wasting and underweight in children younger than 2 years of age. Mortality rates in children younger than 5 years of age decreased by 22% in Millennium Village sites relative to baseline (absolute decrease 25 deaths per 1000 live births, p=0.015) and 32% relative to the matched comparison sites (30 deaths per 1000 live births, p=0.033). Regrettably, no information was reported on exclusive breastfeeding rates or timely introduction of complementary feeding. The authors concluded that the integrated, multi-sectoral approach produced a rapid decline in child mortality in the study communities.

Program and Policy Implications
These results provide encouraging evidence that accelerated progress in achieving the MDGs, including reductions in child mortality, is possible in rural areas of sub-Saharan Africa. The authors suggest that integrated approaches that deliver health-sector inputs alongside broader investments in agriculture, nutrition, environment, and basic infrastructure hold great potential. Major challenges for the health-related interventions were related to commodity procurement and supply chain management, improving health-worker performance at clinical facilities and building the capacity of community-based, front-line health-workers. The authors hypothesized that these systemic weaknesses prevented major shifts in health-sector outcomes, which require a continuum of skilled health care personnel who are capable of providing diarrhea and pneumonia case management, antenatal care and postnatal examinations. Because no information was reported from in-depth nutritional assessments, little is known about the impact of the interventions on breastfeeding behaviors, age-appropriate complementary feeding practices, and specific aspects of young children’s nutritional status.

NNA Editors’ comments*
Integrating nutrition interventions into a multi-sectoral development program, such as that applied in the Millennium Village Project, is promising; and nutritionists should seek opportunities for promoting the nutrition agenda within this type of broad-based development projects. More information is needed on the impact and effectiveness of these integrated programs on nutritional outcomes.  Ideally, the impact assessment of any new program should be planned prior to the implementation of the intervention, so that the evaluation can be designed to strengthen the study conclusions. In the present study, no comparison villages were included initially because of ethical concerns regarding the inclusion of these communities without offering any additional programmatic inputs.  However, because the intervention and comparison villages were not randomly assigned initially, a true baseline comparison was not possible, which leaves the current findings open to criticism (3).  It is possible that the reported effects may not be specifically or entirely related to the intervention.

Because all interventions of the MVP were implemented at about the same time in all nine sites, it is not possible to evaluate which of the multiple interventions were most effective and whether any specific interventions might need further improvement. Considering the high investment costs and concerns raised about their sustainability (3), better understanding of the cost-effectiveness of the different program components would be useful. As new programs are being considered, program managers, public health experts and scientists should work closely with each other to optimize the program implementation and ensure suitable evaluations are planned to guide ongoing and future programs.

1.       Remans R, Pronyk PM, Fanzo JC, et al. Multisector intervention to accelerate reductions in child stunting: an observational study from 9 sub-Saharan African countries. Am J Clin Nutr 94: 1632-42; 2011. http://www.ajcn.org/content/94/6/1632.abstract
2.       Sanchez P, Palm C, Sachs J, et al. The African Millennium Villages. Proc Natl Acad Sci USA 204 : 16775-80 : 2007. http://www.pnas.org/content/104/43/16775.full.pdf+html
3.       Malenga G, Molyneux M. The Millennium Villages project. The Lancet DOI:10.1016/S0140-6736(12)60369-9. http://press.thelancet.com/mv.pdf
*These comments have been added by the editorial team and are not part of the cited publication.

Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Need for Routine Antibiotics as Part of the Outpatient Management of Severe Acute Malnutrition

In Under-nutrition on August 11, 2012 at 11:23 am

by Mark J. Manary, Kenneth Maleta, Indi Trehan
Food and Nutrition Technical Assistance II Project (FANTA-2) Bridge, FHI
360, March 2012

(download the entire document)

The Food and Nutrition Technical Assistance (FANTA) Project undertook a clinical trial comparing nutritional recovery and mortality outcomes in children with severe acute malnutrition (SAM) receiving 1 week of amoxicillin, cefdinir, or placebo, in addition to usual peanut-based ready-to-use therapeutic food (RUTF) therapy. This report documents the outcomes of the trial, which clearly showed the benefit of using antibiotics in the outpatient treatment of SAM without medical complications in a setting with high levels of kwashiorkor and HIV infection.

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