Effectiveness of acute malnutrition treatment with a simplified, combined protocol in Central African Republic: An observational cohort study.

A simplified, combined protocol admitting children with a mid-upper-arm circumference (MUAC) of <125 mm or oedema to malnutrition treatment with ready-to-use therapeutic food (RUTF) uses two sachets of RUTF per day of those with MUAC < 115 mm and/or oedema and one sachet of RUTF per day for those with MUAC 115-<125 mm. This treatment previously demonstrated noninferior programmatic outcomes compared with standard treatment and high recovery in a routine setting. We aimed to observe the protocol's effectiveness in a routine setting at scale, in two health districts of the Central African Republic through an observational cohort study. The pilot enrolled children for 1 year in consortium by the Ministry of Health and nongovernmental partners. A total of 7909 children were admitted to the simplified, combined treatment. Treatment resulted in an 81.2% overall recovery, with a mean length of stay (LOS) of 38.7 days and a mean RUTF consumption of 43.4 sachets per child treated. Among children admitted with MUAC < 115 mm or oedema, 67.9% recovered with a mean LOS of 48.1 days and consumed an average of 70.9 RUTF sachets. Programme performance differed between the two districts, with an overall defaulting rate of 31.1% in the Kouango-Grimari health district, compared to 8.2% in Kemo. Response to treatment by children admitted with severe acute malnutrition (SAM) by MUAC and SAM by oedema was similar. The simplified, combined protocol resulted in a satisfactory overall recovery and low RUTF consumption per child treated, with further need to understand defaulting in the context.

An Alternative Oat-Containing, Ready-To-Use, Therapeutic Food Does Not Alter Intestinal Permeability or the 16S Ribosomal RNA Fecal Microbiome Configuration Among Children With Severe Malnutrition in Sierra Leone: A Randomized Controlled Trial.

BACKGROUND: Previously, a novel oat ready-to-use therapeutic food (o-RUTF) resulted in improved recovery from severe acute malnutrition (SAM) when compared to a standard RUTF (s-RUTF). The o-RUTF contained 18% oat, while the s-RUTF has no cereal ingredients. OBJECTIVES: We determined the effects of o-RUTF on intestinal permeability, as measured by lactulose permeability, and the 16S ribosomal RNA (rRNA) fecal microbiome configuration of children with SAM. METHODS: This was a prospective, randomized, double-blinded, controlled clinical trial. Sierra Leonean children aged 6-59 mo with SAM, defined by a midupper arm circumference < 11.5 cm, were randomized to receive o-RUTF or s-RUTF. All children received 7 d of amoxicillin per guidelines. Lactulose permeability testing and fecal 16S rRNA sequencing were performed at baseline and after 4 wk of therapy. The change in lactulose permeability was the primary outcome, while the fecal 16S rRNA configuration at 4 wk was a secondary outcome. RESULTS: Of the 129 children enrolled, lactulose permeability testing was completed by 100 at baseline and 82 at week 4. After 4 wk of therapeutic feeding, there were no differences in lactulose permeability between the o-RUTF and s-RUTF groups (P = 0.84), and over half of children had increased lactulose permeability (50% s-RUTF compared with 58% o-RUTF, mean difference = -7.5%; 95% CI: -29.2, 15.2; P = 0.50). After 4 wk of feeding, there were no differences in the 16S rRNA configurations between the o-RUTF and s-RUTF groups (Permanova, 999 permutations; P = 0.648; pseudo-F = 0.581), nor were there differences in α or ß diversity. CONCLUSIONS: Despite remarkably different compositions of o-RUTF and s-RUTF, no differences were identified in lactulose permeability or the fecal 16S rRNA configuration among children with SAM receiving these foods. These results suggest that the o-RUTF exerts its beneficial effects through mechanisms other than reducing intestinal permeability or altering the fecal 16S configuration. This trial was registered at clinicaltrials.gov as NCT04334538.

Effect of ready-to-use therapeutic foods on time to recovery among children with severe acute malnutrition in Ethiopia: a prospective cohort study.

BACKGROUND: The therapeutic feeding unit (TFU) provides comprehensive inpatient clinical care for children suffering from severe acute malnutrition (SAM) in three stages: stabilization, transition, and rehabilitation. During the transitional and rehabilitation phases, children receive either F-100 or ready-to-use therapeutic food (RUTF). Although both promote weight gain, RUTF is more energy dense than F-100. There is limited and contrasting evidence regarding their effect on recovery time. Therefore, this study aimed to assess the effect of RUTF on time to recovery among SAM children aged 6-59 months admitted to the TFU in Ethiopia. METHODS: Health Facility-based prospective cohort study was conducted among 476 children treated in three hospitals and four health centers in the Sidama region from September 2021 to January 2022. A structured questionnaire adopted from the Ethiopian national protocol for the management of SAM was used for data collection. Data were entered into EpiData version 3.1 and exported to SPSS version 20 for analysis. The Kaplan-Meir curve and log-rank test were used to compare time to recovery between children who received RUTF and F-100. Multivariable Cox proportional hazard analysis was conducted to assess the association between time to recovery and the type of therapeutic food, controlling for the confounding variables. RESULTS: The median recovery time was significantly shorter in children receiving RUTF (7 days; 95% CI: 6.62-7.38) compared to F-100 (10 days; 95% CI: 8.94-11.06). Children below 24 months (AHR = 0.54, 95% CI: 0.42-0.69), dehydrated (AHR = 1.34, 95% CI: 1.07-1.75), edematous malnutrition (AHR = 1.29, 95% CI: 1.03-1.61), and anemic (AHR = 2.57, 95% CI: 1.90-3.48) during admission were associated with time to recovery. CONCLUSIONS: Children who received RUTF recovered faster than children who received F-100. Administering RUTF to children below 24 months, who present with anemia and dehydration can improve their recovery rate and shorten their stay in the health facility.

Efficacy of ready-to-use therapeutic food in malnourished children with cancer: Results of a randomized, open-label phase 3 trial.

BACKGROUND: The adverse influence of undernutrition in children with cancer may be remediated by early nutritional intervention. This study assessed the efficacy of ready-to-use therapeutic food (RUTF) in improving nutritional status and reducing treatment-related toxicities (TRTs) in such children. METHODS: In a randomized controlled phase-3 open-label trial, severely and moderately undernourished children with cancer were randomized 1:1 to receive standard nutritional therapy (SNT) or SNT+RUTF for 6 weeks. The primary outcome (weight gain >10%) and secondary outcomes (improved/maintained nutritional status, improved body composition) were assessed after 6 weeks. TRTs were assessed over 6 months. RESULTS: Between July 2015 and March 2018, 260 subjects were enrolled, 126 were analyzable in both arms at 6 weeks. More children on RUTF had weight gain (98 [77.8%] vs. 81 [64.2%], p = .025) with a greater increase in fat mass as a percentage of body mass (median 2% [IQR -0.12 to 4.9] vs. 0.5% [IQR -1.45 to 2.27, p = .005]) but a greater loss of lean mass (median -1.86% [IQR -4.4 to 0.50] vs. -0.4% [IQR -2.4 to 1.4, p = .007]) compared to the SNT arm. Fewer subjects on the RUTF arm had episodes of severe infection (10.6% vs. 31%, p < .0001), treatment delays (17.7% vs. 39%, p < .0001), and severe mucositis (11% vs. 23.8%, p = .006) compared to the SNT arm. The odds of developing TRTs on the RUTF arm were lower even after adjusting for improvement in nutritional status. CONCLUSIONS: RUTF is efficacious in improving weight gain and nutritional status in undernourished children with cancer and decreases TRTs. Incorporating RUTF into a healthy, balanced diet should be considered in undernourished children with cancer.

Effectiveness of management of severe acute malnutrition (SAM) through community health workers as compared to a traditional facility-based model: a cluster randomized controlled trial.

PURPOSE: We compared the impact of management of severe acute malnutrition (SAM) by lady health workers (LHWs) at a community level with the standard CMAM program provided at the health facility. METHODS: A two-arm cluster randomised controlled trial was conducted in a rural district in sindh Pakistan. The primary outcome was recovery from SAM and secondary outcomes were relapse, defaulter and mortality rate. RESULTS: A total of 829 children were recruited in the trial (430 in intervention and 399 in control groups). No significant difference was noted in recovery rate between the intervention and control groups (79.2% vs 85.6%, p = 0.276). Similarly, no significant differences were noted in relapse (p = 0.757), weight gain (p = 0.609), deaths (p = 0.775) and defaulter rate (p = 0.324) across the groups. Compliance of RUTF was significantly higher in the control group (93%) than in the intervention group (87%), p < 0.000. CONCLUSION: Our results showed no impact of SAM treatment on performance indicators of CMAM (recovery, relapse, death and default) between the standard CMAM programme performed at the health facility by the government and NGO staff and the programme performed at health house level by the LHWs in Pakistan. We recommend further robust trials in other settings to confirm our results.

Protein Quality Assessment of Follow-up Formula for Young Children and Ready-to-Use Therapeutic Foods: Recommendations by the FAO Expert Working Group in 2017.

The FAO of the UN convened an Expert Working Group meeting to provide recommendations related to protein quality evaluation of Follow-up Formula for Young Children (FUF-YC) and Ready-to-Use Therapeutic Foods (RUTFs). The protein and amino acid (AA) scoring patterns for the target age groups were defined and recommendations provided on the use of currently available protein and indispensable AA digestibility data. For FUF-YC, an age category of 1-2.9 y was identified, and a matching protein requirement of 0.86 g · kg-1 · d-1 with corresponding AA requirements were recommended. For RUTF, the protein requirement recommended was 2.82 g · kg-1 · d-1, to achieve a catch-up weight gain of 10 g · kg-1 · d-1 in children recovering from severe acute malnutrition. The AA requirements were factorially derived based on the adult protein requirement for maintenance and tissue AA composition. A flowchart was proposed for the best available methods to estimate digestibility coefficients (of either protein or AAs), in the following order: human, growing pig, and rat true ileal AA digestibility values. Where this is not possible, fecal protein digestibility values should be used. The Expert Working Group recommends the use of the Protein Digestibility Corrected Amino Acid Score (PDCAAS), with existing protein digestibility values, or the Digestible Indispensable Amino Acid Score provided that individual AA digestibility values are available for protein quality evaluation using the latter score. The Group also recommends the use of ileal digestibility of protein or of AAs for plant-based protein sources, recognizing the possible effects of antinutritional factors and impaired gut function. A PDCAAS score of ≥90% can be considered adequate for these formulations, whereas with a score <90%, the quantity of protein should be increased to meet the requirements. Regardless of the protein quality score, the ability of formulations to support growth in the target population should be evaluated. Future research recommendations are also proposed based on the knowledge gaps identified.

Acceptability and efficacy of ready-to-use therapeutic food using soy protein isolate in under-5 children suffering from severe acute malnutrition in Bangladesh: a double-blind randomized non-inferiority trial.

BACKGROUND AND OBJECTIVE: Globally, around 20 million children suffer from severe acute malnutrition (SAM). Identifying a more economical treatment for those affected has the potential to make treatment more available and improve prognosis for recovery and future health. DESIGN/METHODS: The double-blind randomized study compared taste acceptability (measured by the eagerness to eat) and efficacy of soy-based RUTF (S-RUTF) with milk-based RUTF (M-RUTF) in 6- to 59-month-old children suffering from SAM (WHZ < -3) at icddr,b, in Bangladesh. These SAM children were enrolled in the study after completion of their stabilization phase of treatment. Tolerance of test-RUTF was also tested during the efficacy trial. RESULTS: The cross-over taste acceptability study, conducted in 36 children, revealed similar results between products and an absence of side effects. The efficacy trial enrolled 260 children (130, each group) with similar baseline characteristics, including mean ± SD age 15.0 ± 8.0 months, WHZ - 3.41 ± 0.40 and mid-upper arm circumference (MUAC) 11.1 ± 0.7 cm. The features at the end of study by RUTF group were (in S-RUTF vs. M-RUTF, respectively): total days from enrollment: 44 ± 34 versus 39 ± 30; weight gain (kg): 0.698 ± 0.438 versus 0.741 ± 0.381 and rate of weight gain (g/kg/d): 3.9 ± 3.2 versus 5.2 ± 4.6; MUAC gain (cm): 0.9 ± 0.7 versus 0.9 ± 0.6; and improvement of WHZ: 1.12 ± 0.82 versus 1.22 ± 0.68 (all data were man ± SD and none were significantly different between the groups). At enrollment and the end of intervention, the body composition [total body water (TBW): 70.3 ± 3.2 vs. 69.9 ± 3.5%, and fat: 11.0 ± 4.0 vs.11.5 ± 4.3% at baseline; and TBW: 65.5 ± 4.1 vs. 65.9 ± 4.6%; and fat: 16.8 ± 5.2 vs. 16.2 ± 5.8% in S-RUTF and M-RUTF group, respectively] was found similar. Moreover, the increment of total TBW, FM, and FFM was also observed similar between the groups. CONCLUSIONS: This is the first randomized trial comparing S-RUTF using soy protein isolate with milk-based RUTF including comparison of body composition. S-RUTF was found equally acceptable as of milk-based RUTF without any adverse event. Children receiving S-RUTF showed similar pattern of changes in anthropometric indices, and body composition as of milk-based RUTF. Greater number of SAM children can be managed in the community with comparatively low-cost soy-based RUTF. TRIAL REGISTRATION: NCT01634009.

Development and testing of locally-produced ready-to-use therapeutic and supplementary foods (RUTFs and RUSFs) in Cambodia: lessons learned.

BACKGROUND: Rates of childhood undernutrition are persistently high in Cambodia. Existing ready-to-use supplementary and therapeutic foods (RUSFs and RUTFs) have had limited acceptance and effectiveness. Therefore, our project developed and trialled a locally-produced, multiple micronutrient fortified lipid-based nutrient supplement (LNS) with therapeutic and supplementary versions. This ready-to-use food (RUF) is innovative in that, unlike many RUFs, it contains fish instead of milk. Development began in 2013 and the RUF was finalised in 2015. From 2015 until the present, both the RUTF and the RUSF versions were trialled for acceptability and effectiveness. METHODS: This paper draws on project implementation records and semi-structured interviews to describe the partnership between the Cambodian Ministries of Health and Agriculture, Forestry and Fisheries, UNICEF, the French National Research Institute for Sustainable Development (IRD), universities, and Vissot factory. It discusses the project implementation and lessons learned from the development and trialling process, and insights into positioning nutrition on the health agenda in low and middle-income countries. RESULTS: The lessons learned relate to the importance of project planning, management, and documentation in order to seize opportunities in the research, policy, advocacy, and programming environment while ensuring adequate day-to-day project administration and resourcing. CONCLUSIONS: We conclude that projects such as ours, that collaborate to develop and test novel, locally-produced RUTFs and RUSFs, offer an exciting opportunity to respond to both local programmatic and broader research needs.

Milk products in the dietary management of childhood undernutrition - a historical review.

The present narrative review outlines the use of milk products in infant and young child feeding from early history until today and illustrates how research findings and technical innovations contributed to the evolution of milk-based strategies to combat undernutrition in children below the age of 5 years. From the onset of social welfare initiatives, dairy products were provided by maternal and child health services to improve nutrition. During the last century, a number of aetiological theories on oedematous forms of undernutrition were developed and until the 1970s the dogma of protein deficiency was dominant. Thereafter, a multifactorial concept gained acceptance and protein quality was emphasised. During the last decades, research findings demonstrated that the inclusion of dairy products in the management of severe acute malnutrition is most effective. For children suffering from moderate acute malnutrition the evidence for the superiority of milk-based diets is less clear. There is an unmet need for evaluating locally produced milk-free alternatives at lower cost, especially in countries that rely on imported dairy products. New strategies for the dietary management of childhood undernutrition need to be developed on the basis of research findings, current child feeding practices, socio-cultural conditions and local resources. Exclusive and continued breast-feeding supported by community-based nutrition programmes using optimal combinations of locally available complementary foods should be compared with milk product-based interventions.

Transition from F-75 to ready-to-use therapeutic food in children with severe acute malnutrition, an observational study in Uganda.

BACKGROUND: World Health Organization now recommends the transition from F-75 to ready-to-use therapeutic foods (RUTF) in the management of severe acute malnutrition (SAM). We described the transition from F-75 to RUTF and identified correlates of failed transition. METHODS: We conducted an observational study among children aged 6-59 months treated for SAM at Mulago hospital, Kampala, Uganda. Therapeutic feeding during transition phase was provided by first offering half of the energy requirements from RUTF and the other half from F-75 and then increasing gradually to RUTF as only energy source. The child was considered to have successfully transitioned to RUTF if child was able to gradually consume up to 135 kcal/kg/day of RUTF in the transition phase on first attempt. Failed transition to RUTF included children who failed the acceptance test or those who had progressively reduced RUTF intake during the subsequent days. Failure also included those who developed profuse diarrhoea or vomiting when RUTF was ingested. RESULTS: Among 341 of 400 children that reached the transition period, 65% successfully transitioned from F-75 to RUTF on first attempt while 35% failed. The median (IQR) duration of the transition period was 4 (3-8) days. The age of the child, mid-upper arm circumference, weight-for-height z-score and weight at transition negatively predicted failure. Each month increase in age reflected a 4% lower likelihood of failure (OR 0.96 (95% CI 0.93; 0.99). Children with HIV (OR 2.73, 95% CI 1.27; 5.85) and those rated as severely ill by caregiver (OR 1.16, 95% CI: 1.02; 1.32) were more likely to fail. At the beginning of the rehabilitation phase, the majority (95%) of the children eventually accepted RUTF while only 5% completed rehabilitation in hospital on F-100. CONCLUSION: Transition from F-75 to RUTF for hospitalized children with SAM by gradual increase of RUTF was possible on first attempt in 65% of cases. Younger children, severely wasted, HIV infected and those with severe illness as rated by the caregiver were more likely to fail to transit from F-75 to RUTF on first attempt.

Local versus offshore production of ready-to-use therapeutic foods and small quantity lipid-based nutrient supplements.

Manufacturers on four continents currently produce ready-to-use therapeutic foods (RUTF). Some produce locally, near their intended users, while others produce offshore and ship their product long distances. Small quantity lipid-based nutrient supplements (SQ-LNS) such as Nutriset's Enov'Nutributter are not yet in widespread production. There has been speculation whether RUTF and SQ-LNS should be produced primarily offshore, locally, or both. We analyzed The United Nations Children's Fund (UNICEF) Supply Division data, reviewed published literature, and interviewed local manufacturers to identify key benefits and challenges to local versus offshore manufacture of RUTF. Both prices and estimated costs for locally produced product have consistently been higher than offshore prices. Local manufacture faces challenges in taxation on imported ingredients, low factory utilization, high interest rates, long cash conversion cycle, and less convenient access to quality testing labs. Benefits to local economies are not likely to be significant. Although offshore manufacturers offer RUTF at lower cost, local production is getting closer to cost parity for RUTF. UNICEF, which buys the majority of RUTF globally, continues to support local production, and efforts are underway to narrow the cost gap further. Expansion of RUTF producers into the production of other ready-to-use foods, including SQ-LNS in order to reach a larger market and achieve a more sustainable scale, may further close the cost and price gap. Local production of both RUTF and SQ-LNS could be encouraged by a favorable tax environment, assistance in lending, consistent forecasts from buyers, investment in reliable input supply chains, and local laboratory testing.

Changes in whole-blood PUFA and their predictors during recovery from severe acute malnutrition.

Children with severe acute malnutrition (SAM) with complications require in-patient management including therapeutic feeding. Little attention has been given to the effects of these feeds on the essential fatty acid status of children with SAM. The objective of this study was to describe changes in the PUFA composition in whole blood in children with SAM during treatment and to determine predictors of change. This prospective study took place in a paediatric nutrition rehabilitation unit in Kampala, Uganda, and assessed whole-blood fatty acid composition of children with SAM at admission, transition, discharge and follow-up (8 and 16 weeks). ANCOVA was used to identify predictors of change in whole-blood PUFA. The study included 120 children with SAM and twenty-nine healthy control children of similar age and sex. Among the SAM children, 38 % were female and 64 % had oedema. Whole-blood n-6 PUFA proportions increased from admission to follow-up, except for arachidonic acid, which decreased by 0·79 (95 % CI 0·46, 1·12) fatty acid percentage (FA%) from admission to transition and 0·10 (95 % CI 0·23, 0·44) FA% at discharge. n-3 Long-chain (LC) PUFA decreased by 0·21 (95 % CI 0·03, 0·40) FA% at discharge and 0·22 (95 % CI 0·01, 0·42) FA% at 8 weeks of follow-up. This decrease was greater in children from families with recent fish intake and those with nasogastric tube feeding. Current therapeutic feeds do not correct whole-blood levels of LCPUFA, particularly n-3 LCPUFA, in children with SAM. Increased attention is needed to the contents of n-3 LCPUFA in therapeutic feeds.

Effectiveness And Acceptability Of Ready-To-Use Therapuetic Foods Among Malnourished Children In A Tertiary Care Hospital.

BACKGROUND: Ready-to-use-therapeutic foods (RUTF) are an important component of the effective outpatient treatment of severe wasting because most of the child deaths in the world especially in developing countries is due to malnutrition. The objective of the study was to evaluate the effectiveness and acceptability of ready to use therapeutic food among malnourished children in a tertiary care hospital. METHODS: An observational exploratory study based on sixty subjects with 3-120 months of age, malnourished children were chosen by universal sampling from Children Hospital Lahore, Pakistan, during the time period 1st September 2012 to 30th November 2012 with the approval of ethical committee. The study tool for investigation was a well-structured questionnaire. RESULTS: The highest proportion of malnourished children belonged to urban areas (71.67%) and age group <24 months (65%).The effect of RUTF on weight for height and weight for age Z score from baseline to the end of follow-up was statistically significant (Paired sample t-test) (p=0.000, 0.000) but there was no significant effect of RUTF on height for age (p-value=0.14).The acceptance of food among patients was good, the proportion of patient was higher who consumed ready to use therapeutic food easily (70%), percentage of vomiting (16.7%) and complaints of diarrhoea (46.7%) after taking RUTF was less in patients. All mothers were satisfied from ready to use therapeutic foods (100%). CONCLUSIONS: Malnourished children gained weight after the short term supplementation of ready to use therapeutic food but had no significant effect on height of the patients. Its acceptability in term of taste, amount consumes and demand was good. Mother's perception was also satisfactory regarding these foods.

Acceptability of Two Ready-to-Use Therapeutic Foods by HIV-Positive Patients in Vietnam.

BACKGROUND: Ready-to-use therapeutic food (RUTF) has been found effective in treating severe acute malnutrition. Vietnam's National Institute of Nutrition (NIN), the Institut de Recherche pour le Développement (IRD), and UNICEF collaborated to formulate a local RUTF called High-Energy Bar for Integrated Management of Acute Malnutrition (HEBI). RUTF might be useful to address malnutrition in HIV patients. OBJECTIVE: To compare the acceptability of the local RUTF and an imported RUTF among malnourished people with HIV in Vietnam Methods: The acceptability of HEBI and Plumpy'Nut was studied among 80 HIV-positive children and 80 HIV-positive adults. In a crossover design, participants were randomly assigned to receive either Plumpy'Nut or HEBI for 2 weeks and were switched to the other product for the subsequent 2 weeks. A third (control) group of about 40 HIV-positive participants in each study was randomly assigned to receive no RUTF. Nurses took anthropometric measurements weekly, and the subjects or their caregivers monitored daily RUTF intake. RESULTS: Children consumed 69% of HEBI and 65% of Plumpy'Nut (p = .13). Adults consumed 91% of HEBI and 81% of Plumpy'Nut (p = .059). Both children (p = .058) and adults (p ≤ .0001) preferred HEBI. Significant gains were observed in percent weight (p = .035), weight-for-age (p = .014), and body mass index (BMI)-for-age (p = .036) in children who received RUTF and in percent weight (p = .017) and BMI (p = .0048) in adults who received RUTF compared with the control groups. CONCLUSIONS: In this study in Vietnam, both HEBI and Plumpy'Nut were found acceptable by people with HIV.

Peanut-based ready-to-use therapeutic food: how acceptable and tolerated is it among malnourished pregnant and lactating women in Bangladesh?

Within a Medecins Sans Frontieres's nutrition programme in Kamrangirchar slum, Dhaka, Bangladesh this study was conducted to assess the acceptability of a peanut-based ready-to-use therapeutic food (RUTF) - Plumpy'nut(®) (PPN) among malnourished pregnant and lactating women (PLW). This was a cross-sectional survey using semi-structure questionnaire that included all PLW admitted in the nutrition programme, who were either malnourished or at risk of malnutrition and who had received PPN for at least 4 weeks. A total of 248 women were interviewed of whom 99.6% were at risk of malnutrition. Overall, 212 (85%) perceived a therapeutic benefit. Despite this finding, 193 (78%) women found PPN unacceptable, of whom 12 (5%) completely rejected it after 4 weeks of intake. Reasons for unacceptability included undesirable taste (60%) and unwelcome smell (43%) - more than half of the latter was due to the peanut-based smell. Overall, 39% attributed side effects to PPN intake including nausea, vomiting, diarrhoea, abdominal distension and pain. Nearly 80% of women felt a need to improve PPN - 82% desiring a change in taste and 48% desiring a change in smell. Overall, only 146 (59%) understood the illustrated instructions on the package. Despite a perceived beneficial therapeutic effect, only two in 10 women found PPN acceptable for nutritional rehabilitation. We urge nutritional agencies and manufacturers to intensify their efforts towards developing more RUTF alternatives that have improved palatability and smell for adults and that have adequate therapeutic contents for treating malnourished PLW in Bangladesh.

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.

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.

Development and acceptability of a novel milk-free soybean-maize-sorghum ready-to-use therapeutic food (SMS-RUTF) based on industrial extrusion cooking process.

Peanut milk-based ready-to-use therapeutic food (P-RUTF) primarily used to treat severe acute malnutrition at community setting is expensive. We developed an alternative milk-free soybean-maize-sorghum-based RUTF (SMS-RUTF) using locally grown ingredients that have the potential to support local economy and reduce the cost of RUTF. We describe the production process and results of acceptability of the new product. Acceptability and tolerance of SMS-RUTF was compared with P-RUTF among 45 children aged 4-11 years old based on a cross-over design. Each child consumed 250 g RUTF for 10 days followed by a five-day washout period and a subsequent 10-day period on the second RUTF. The SMS-RUTF was as acceptable as the P-RUTF among normal children aged 4-11 years of age with no associated adverse effects. SMS-RUTF was stable for at least 12 months without detectable microbiological or chemical deterioration. The major challenge encountered in SMS-RUTF development was the difficulty to accurately determine key nutrient composition due to its high oil content. Use of diversified locally available ingredients to produce RUTF is feasible. The SMS-RUTF meets expected standards and is acceptable to children aged 4-11 months old. Effectiveness and cost-effectiveness of SMS-RUTF is required.

Effectiveness of indigenous ready-to-use therapeutic food in community-based management of uncomplicated severe acute malnutrition: a randomized controlled trial from India.

A randomized controlled trial was conducted in Chandigarh, India (2011), to determine the effectiveness of indigenous ready-to-use therapeutic food (RUTF) in community-based management of uncomplicated severe acute malnutrition (SAM). Intervention was through outpatient therapeutic program site (OTP). Study and control group children (6 months-5 years) were followed up weekly for 12 weeks, in OTP and at home. All children received supplementary nutrition through anganwadis under integrated child development scheme. Study children, in addition, received therapeutic dose of RUTF in OTP. Primary outcome, 115% of baseline weight, was attained in 6 of 13 (46.2%) and 1 of 13 (7.7%) children among study and control group, respectively [odds ratio: 10.28, 95% confidence interval (CI): 1.02-103.95]. Compared with control group, addition of RUTF in study group resulted in average additional increase in weight by 13 g/kg of baseline weight/week/child (95% CI: 2-23). Indigenous RUTF was effective in community-based management of uncomplicated SAM.

Double-Blind Parallel Treatment Randomized Controlled Trial of Prebiotics' Efficacy for Children Experiencing Severe Acute Malnutrition in Southern Punjab, Pakistan.

The prevalence of malnutrition among children under five is alarmingly high in Pakistan. However, there are ready-to-use therapeutic foods (RUTF) available which may be used to treat children with severe acute malnutrition (SAM). This study aims to assess the efficacy of prebiotics as a synergistic additive to RUTF to enhance blood parameters and anthropometric measurements in children with uncomplicated SAM living in Southern Punjab, Pakistan. A double-blind parallel treatment randomized controlled trial was conducted on 204 children aged 6-59 months. Participants were randomized and allocated to the placebo (n = 102) or experimental arms (n = 102) in a 1:1 ratio. One group of children was provided with RUTF and 4 g prebiotics, while the other group was given RUTF and starch as a placebo. Participants recruited for both arms were given treatment for eight weeks, and then their biochemical and anthropometric outcomes were evaluated. A substantial difference between the mean weight, mid-upper-arm circumference, haemoglobin, haematocrit, platelet count, mean corpuscular volume, mean corpuscular haemoglobin, and albumin was revealed. During the two-month follow-up phase of the trial, children who were enrolled in the treatment group gained about 20% of their initial weight (pre-study mean weight = 5.44 ± 1.35 kg; post-study mean weight = 6.53 ± 1.45 kg). The analysis showed a significant difference (p < 0.005) between the control and treatment groups for MUAC and complete blood counts. Conclusively, supplementation with RUTF and prebiotics has proven to be an efficient, effective, and safe therapy for children suffering from SAM to improve their growth and development indicators and reduce the dangers of malnutrition in comparison to RUTF alone.

Cost of Acute Malnutrition Treatment Using a Simplified or Standard Protocol in Diffa, Niger.

Evidence on the cost of acute malnutrition treatment, particularly with regards to simplified approaches, is limited. The objective of this study was to determine the cost of acute malnutrition treatment and how it is influenced by treatment protocol and programme size. We conducted a costing study in Kabléwa and N'Guigmi, Diffa region, where children with acute malnutrition aged 6-59 months were treated either with a standard or simplified protocol, respectively. Cost data were collected from accountancy records and through key informant interviews. Programme data were extracted from health centre records. In Kabléwa, where 355 children were treated, the cost per child treated was USD 187.3 (95% CI: USD 171.4; USD 203.2). In N'Guigmi, where 889 children were treated, the cost per child treated was USD 110.2 (95% CI: USD 100.0; USD 120.3). Treatment of moderate acute malnutrition was cheaper than treatment of severe acute malnutrition. In a modelled scenario sensitivity analysis with an equal number of children in both areas, the difference in costs between the two locations was reduced from USD 77 to USD 11. Our study highlighted the significant impact of programme size and coverage on treatment costs, that cost can differ significantly between neighbouring locations, and that it can be reduced by using a simplified protocol.