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NCT06154174
The goal of this clinical trial is to test adding choline to ready-to-use therapeutic food (RUTF) in children with severe acute malnutrition (SAM) in Malawi. The main question it aims to answer is: \- Will the addition of a 500mg daily dose of choline to RUTF during treatment for SAM improve cognitive development among 6-59-month-old Malawian children compared with standard RUTF without added choline?
NCT06869850
The goal of this clinical trial is to test the use of milk fat globule membrane (MFGM) in ready-to-use therapeutic food (RUTF) in children with severe acute malnutrition in Sierra Leone. The main questions it aims to answer are: * Will the inclusion of MFGM in RUTF for 6-59-month-old Sierra Leonean children with severe acute malnutrition improve their neurodevelopment? * Will the inclusion of MFGM in RUTF for 6-59-month-old Sierra Leonean children with severe acute malnutrition reduce its worst consequences: death, hospitalization, and remaining severely malnourished despite treatment? Researchers will compare the MFGM-containing RUTF to standard RUTF, which contains skim milk powder. Participants will: * undergo measurement of length, weight, mid-upper arm circumference, and nutritional edema assessment every two weeks during severe malnutrition treatment * be treated with either MFGM-RUTF or standard RUTF at a dose of 2 sachets per day for up to 12 weeks * undergo neurodevelopmental testing using the Malawi Developmental Assessment Tool at the end of SAM treatment and 6 months later * a subset of participants will undergo blood spot collection and stool sample collection
NCT04240990
TB-Speed SAM is a multicentric, prospective diagnostic cohort study conducted in two countries with high and very high TB incidence (Uganda and Zambia). It aims at assessing several diagnostic tests that could result in the development of a score and algorithm for TB treatment decision in hospitalised children with severe acute malnutrition (SAM).
NCT06010719
Amoxicillin is recommended by the World Health Organization (WHO) as adjunctive therapy for the treatment of uncomplicated severe acute malnutrition (SAM). Because children with uncomplicated SAM may have asymptomatic infection due to immune suppression, presumptive treatment with a broad-spectrum antibiotic may be beneficial by clearing any existing infection and improving outcomes. Two randomized placebo-controlled randomized trials have evaluated amoxicillin for uncomplicated SAM and have found conflicting results. These results may indicate either that antibiotics are not helpful for the management of uncomplicated SAM, or that a better antibiotic is needed. Recently, the investigators demonstrated that biannual mass azithromycin distribution as a single oral dose reduces all-cause child mortality in sub-Saharan Africa. Children with uncomplicated SAM, who have an elevated risk of mortality relative to their well-nourished peers, may particularly benefit from presumptive azithromycin treatment. Our pilot data demonstrated feasibility in rapid enrollment of children with uncomplicated SAM in our study area, and showed no significant difference between azithromycin and amoxicillin, demonstrating equipoise for a full-scale trial. Here, the investigators propose an individually randomized trial in which children will be randomized to a) azithromycin, b) amoxicillin, or c) placebo, and evaluated for differences in weight gain, nutritional recovery, and the gut microbiome. The results of this study will strengthen the evidence base for policy related to the use of antibiotics as part of the management of uncomplicated SAM, including additional evidence of amoxicillin versus placebo as well as evaluation of an antibiotic class that has not been considered for uncomplicated SAM, which may lead to changes in guidelines for treatment.
NCT07070856
The goal of this study is to find out if a rice-based version of the F-75 therapeutic food helps children with severe acute malnutrition (SAM) and persistent diarrhea recover better than the standard commercial F-75. The main questions it aims to answer are: 1. Does rice-based F-75 reduce the duration of diarrhea and improve nutritional recovery in children with SAM? 2. Is rice-based F-75 as safe and well-tolerated as the standard WHO F-75? Researchers will compare two groups: One group will receive the new rice-based F-75. The other group will receive the standard F-75. Participants will: 1. Be children aged 6 to 59 months admitted with SAM and persistent diarrhea 2. Be randomly assigned to one of the two feeding groups 3. Stay in a hospital ward for monitoring during the stabilization phase Be assessed daily for: Stool frequency Weight changes Appetite Medical problems or side effects This study will help determine whether the rice-based F-75 is a better option for malnourished children with diarrhea.
NCT06038071
Protocols for the community-based management of acute malnutrition (CMAM) have not changed significantly for more than 20 years, with relatively complex treatment protocols and persistent supply chain challenges that have limited overall program coverage, leaving millions of malnourished children without care annually. The overarching goal of this research project is to simultaneously test two novel simplified approaches in CMAM with potential to improve program coverage. The simplified approach includes two parallel clinical trials for SAM and MAM treatment. For the Family MUAC follow-up study, children who recover from these two parallel clinical trials will be enrolled in trial to test the effectiveness of MUAC screening at home by the child's caregivers as a self-referral strategy, compared to a scheduled health facility-led strategy and the standard of care of community-based follow-up visits.
NCT04667767
This study evaluates the addition of a simple, scalable "WASH kit", including household water treatment products, a safe water storage container, and hygiene promotion, to the standard national protocol for outpatient treatment of uncomplicated severe acute malnutrition among children aged 6-59 months of age in northern Senegal.
NCT05614505
Severe wasting or Severe Acute Malnutrition (SAM) continues to be a major public health problem in Indonesia, affecting more than 2 million children under 5 years old. A new approach to treat SAM is called Community-based management of acute malnutrition (CMAM), which has been designed to maximize the coverage and successful treatment of children with SAM, by providing Ready to Use Therapeutic Food (RUTF) through out-patient treatment. Since 2019, UNICEF has been working intensively to facilitate the local production of RUTF. This present study aims to assess the acceptability and efficacy of three locally produced RUTFs compared to the standard peanut based RUTF. The study will be implemented in Bogor district. A total of 300 children with uncomplicated SAM, aged 6-59 months old, meeting the inclusion criteria will be included in the study. This study is designed as a randomized controlled trial. The children will be allocated to one of the five intervention (1 control, 4 experimental) arms. Each child will receive one type of RUTF product for eight consecutive weeks. The ration given to a child will be based on the need for an intake of \~ 170 kcal/kg BW/day. Data will be collected at baseline, at weekly intervals and at exit. The primary outcome of interest for the efficacy study is the relative weight gain of children consuming each of the local RUTFs compared with those consuming the standard RUTF. The primary outcome of the acceptability of the RUTFs will be the amount of product consumed during the eight-week efficacy trial. Differences in weight and height gain will be analyzed using ANCOVA, controlling for age, gender, food intake, and morbidity. Repeated measurement statistics will be used to analyze differences in growth patterns over the eight-week intervention.
NCT03094247
An appropriate balance of omega-6 and omega-3 fatty acids is important for support of neurocognitive development in healthy infants and toddlers. In young children recovering from severe acute malnutrition (SAM), excess omega-6 intake depletes omega-3 fatty acid status. This research will evaluate how novel ready-to-use therapeutic foods (RUTF) with balanced fatty acids improve the metabolic and neurocognitive effects in young children in Malawi recovering from SAM, yielding new knowledge that also has implications for development of well-nourished children.
NCT01889329
Around 0.5 million under-five children are currently suffering from severe acute malnutrition (SAM) in Bangladesh and are at risk of death. Children with SAM and complications should be treated in a health care facility. It is imperative, however, to manage children with SAM but without any complications in the community. This requires a ready-to-use-therapeutic food (RUTF) that conforms to standard recommendations on its composition. The prototype RUTF is peanut based, made outside Bangladesh, and has to be imported. By developing a RUTF using local food ingredients, test it for acceptability and efficacy in the treatment of children with SAM, hopefully make the treatment of SAM cost-effective and sustainable. Hypothesis: Does the locally developed ready-to-use-therapeutic foods (RUTFs) demonstrate similar or better acceptability and efficacy in the treatment of children suffering from severe acute malnutrition (SAM) when compared to the prototype RUTF (Plumpynut)?
NCT04715204
The primary outcome of the study is to identify gastrointestinal tolerance of under-five children with severe acute malnutrition to ready-to-drink high energy (1.5 kcal/ml) and standard energy (1 kcal/ml) oral nutrition supplement (ONS) compared to Formula-75/Formula-100. The secondary outcomes of the study are weight gain, electrolyte profile and plasma amino acid profile at the beginning and the end of stabilization phase. In this randomized, controlled trial, 108 patients with severe acute malnutrition will be enrolled. Patients are randomly assigned to 3 groups (Formula-75/Formula-100, high energy ONS, and standard energy ONS) to undergo a two-week treatment. In order to ensure an adequate intake, nasogastric-tube will be placed for home enteral nutrition for at least throughout the two-week study period. Parent or caregiver will be asked to record daily intake, vomit, and defecation score using Bristol stool chart.
NCT04174846
In Pakistan, around 15% of children under five are wasted, which is almost twice that of the global prevalence 7.5%. There is a demand for a reliable and consistent locally available severe acute malnutrition (SAM) treatment option since currently the only option is to use an imported ready-to-use-therapeutic food (RUTF). While imported RUTF is successful for treatment of children with SAM, Pakistan is often faced with supply chain issues and consequentially management of SAM with RUTF is unreliable. The World Food Programme (WFP)'s work in Pakistan supports government-led efforts to improve food and nutrition security, including the development of Acha Mum, a chickpea containing lipid-based ready-to-use-food. Acha Mum replaces the peanut in standard RUTF formulation with chickpea, a locally available legume. Acha Mum is well accepted by children in Pakistan and is currently being used as a treatment for children with moderate acute malnutrition (MAM) in targeted supplementary feeding programs (TSFP) throughout the country. The broad objective of this clinical trial is to test the effectiveness of a chickpea-based specialized nutritious food Acha Mum, compared to a standard RUTF for the treatment of SAM. The study will be conducted in 10 basic health units (BHUs) operating by PPHI in Umerkot district of Sindh, Pakistan. This will be an individual randomized, double-blinded, controlled clinical non-inferiority trial assessing the treatment of SAM with one of two therapeutic foods. A total of 1700 children will be part of the study (850 children in RUTF and 850 children in Acha Mum group). Children aged 6-59 months with SAM, i.e. MUAC \<11.5 cm and/or with bilateral pitting oedema (+, ++), with appetite and without medical complications presenting at selected rural therapeutic feeding clinics. The primary outcome is recovery from SAM, defined as: MUAC ≥ 11.5cm (for two consecutive weekly visits), clinically well, no bilateral pitting oedema (for two consecutive weekly visits). The secondary outcomes include neurocognitive performance after first 4 weeks of treatment as assessed by eye tracking and infant problem solving; changes in MUAC, weight, and length; time to recovery from SAM; time to recovery from MAM defined as achieved a MUAC ≥12.5 cm; relapse into MAM; relapse into SAM and any adverse events.
NCT02994212
Community-based management of severe acute malnutrition (SAM) has been shown to be safe and cost-effective, but program coverage remains low. New treatment models that maintain high levels of clinical effectiveness but allow for increased coverage are still needed. A reduced schedule of follow-up, in which children receive clinical follow-up and therapeutic foods on a monthly rather than weekly or biweekly basis, may be one alternative. This study aims to describe the safety and feasibility of a monthly distribution of ready-to-use therapeutic food in the treatment of uncomplicated SAM, in terms of clinical response to treatment and household ready-to-use therapeutic food (RUTF) utilization. This is a non-randomized pilot intervention study in which 115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF. Anthropometric measurements were taken on a weekly basis for 4 weeks to monitor treatment response defined as weight gain, (mid-upper arm circumference) MUAC gain, weight loss \> 5%, and the development of edema. Unannounced household spot checks were conducted over 4 weeks to assess household utilization of RUTF and storage practices.
NCT03370003
To evaluate, in routine operational settings of treatment of uncomplicated Severe Acute Malnutrition (SAM) in children aged 6-59 months, the risk of nutritional recovery and hospitalization with non-routine use of amoxicillin compared to the risk achieved with systematic use of antibiotics.
NCT03303131
Retrospective analysis of routine program data of children aged 6 to 59 months admitted to the MSF therapeutic feeding program with MUAC ≤ 118 mm in Yako and Titao districts of Burkina Faso from 2007-2011.
NCT01705769
This project aims to assess the efficacy of three options under consideration in India for home management of Severe Acute Malnutrition (SAM). The investigators propose to conduct a multi-center randomized controlled trial to determine the efficacy of two community-supported home-based regimes using centrally or locally produced Ready to Use Therapeutic Foods (RUTF) for recovery from uncomplicated SAM after 16 weeks of management, compared with an augmented home-prepared foods regimen. The trial will enroll 911 children with uncomplicated SAM and will have enough statistical power to detect a 15% or greater difference in recovery rates between either one of the intervention groups compared with comparison group.