Dataset Information

Randomised controlled trial to test the effectiveness of a locally-produced ready-to-use supplementary food (RUSF) in preventing growth faltering and improving micronutrient status for children under two years in Cambodia: a study protocol.

ABSTRACT: BACKGROUND:Existing ready-to-use supplementary and therapeutic foods (RUSFs and RUTFs) have had limited acceptance and effectiveness in Cambodia. This has hampered the treatment and prevention of child malnutrition. An innovative, locally produced, multiple micronutrient fortified lipid-based nutrient supplement (LNS) has been developed for use as an RUSF. Unlike most RUSFs, which contain milk, this product contains fish as the animal protein. Few RUSFs have been formulated using non-milk animal-source foods and they have not been widely tested. An acceptability trial that was conducted on this novel RUSF in June 2015 demonstrated that children will eat the RUSF and that caregivers will feed it to their children. The current trial aims to evaluate the effectiveness of the RUSF in preventing growth faltering and improving micronutrient status in Cambodian children. METHODS AND ANALYSIS:This trial is a six-month, prospective, cluster randomised, non-blinded controlled trial among infants in peri-urban Phnom Penh. The trial aims to establish the superiority of the novel RUSF, compared to three alternatives (Corn-Soy Blend Plus Plus (CSB++) and Sprinkles micronutrient powders as active comparators, and the unimproved diet as a control). The allocation ratio is 1:1. Healthy children (N?=?540) aged six to eleven months will be recruited. Data will be collected at baseline, and monthly thereafter for a period of six months. Participants will be provided with a monthly supply of the food to which their village has been allocated. DISCUSSION:There is an urgent need to develop locally produced and culturally acceptable RUSFs, and to compare these with existing options in terms of their potential for preventing malnutrition, in Cambodia and elsewhere. This trial will contribute much-needed data on the effectiveness of supplementary foods with an animal-source food other than milk, by comparing a novel RUSF based on fish to one that uses milk (CSB++). Moreover, it will deepen the understanding of the impact of multiple micronutrients provided with or without macronutrients, by comparing the novel RUSF and CSB++, which combine macronutrients with multiple micronutrients, to Sprinkles, which contains no macronutrients. In addition, it will augment the body of evidence from Asia. TRIAL REGISTRATION:ClinicalTrials.gov, Identifier: LNS-CAMB-INFANTS-EFF; NCT02257762 .

SUBMITTER: Borg B

PROVIDER: S-EPMC5857085 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Randomised controlled trial to test the effectiveness of a locally-produced ready-to-use supplementary food (RUSF) in preventing growth faltering and improving micronutrient status for children under two years in Cambodia: a study protocol.

Borg Bindi B Mihrshahi Seema S Griffin Mark M Sok Daream D Chhoun Chamnan C Laillou Arnaud A Berger Jacques J Wieringa Frank T FT

Nutrition journal 20180316 1

<h4>Background</h4>Existing ready-to-use supplementary and therapeutic foods (RUSFs and RUTFs) have had limited acceptance and effectiveness in Cambodia. This has hampered the treatment and prevention of child malnutrition. An innovative, locally produced, multiple micronutrient fortified lipid-based nutrient supplement (LNS) has been developed for use as an RUSF. Unlike most RUSFs, which contain milk, this product contains fish as the animal protein. Few RUSFs have been formulated using non-mil ...[more]

PMID: 29548287

Similar Datasets

Project description:Inadequate energy and micronutrient intake during childhood is a major public health problem in developing countries. Ready-to-use supplementary food (RUSF) made of locally available food ingredients can improve micronutrient status and growth of children. The objective of this study was to develop RUSF using locally available food ingredients and test their acceptability.A checklist was prepared of food ingredients available and commonly consumed in Bangladesh that have the potential of being used for preparing RUSF. Linear programming was used to determine possible combinations of ingredients and micronutrient premix. To test the acceptability of the RUSF compared to Pushti packet (a cereal based food-supplement) in terms of amount taken by children, a clinical trial was conducted among 90 children aged 6-18 months in a slum of Dhaka city. The mothers were also asked to rate the color, flavor, mouth-feel, and overall liking of the RUSF by using a 7-point Hedonic Scale (1?=?dislike extremely, 7?=?like extremely).Two RUSFs were developed, one based on rice-lentil and the other on chickpea. The total energy obtained from 50 g of rice-lentil, chickpea-based RUSF and Pushti packet were 264, 267 and 188 kcal respectively. Children were offered 50 g of RUSF and they consumed (mean?±?SD) 23.8?±?14 g rice-lentil RUSF, 28.4?±?15 g chickpea based RUSF. Pushti packet was also offered 50 g but mothers were allowed to add water, and children consumed 17.1?±?14 g. Mean feeding time for two RUSFs and Pushti packet was 20.9 minutes. Although the two RUSFs did not differ in the amount consumed, there was a significant difference in consumption between chickpea-based RUSF and Pushti packet (p?=?0.012). Using the Hedonic Scale the two RUSFs were more liked by mothers compared to Pushti packet.Recipes of RUSF were developed using locally available food ingredients. The study results suggest that rice-lentil and chickpea-based RUSF are well accepted by children.ClinicalTrials.gov NCT01553877. Registered 24 January 2012.

Project description:ObjectiveThis study aimed to determine risk factors of growth faltering by assessing childhood nutrition and household water, sanitation, and hygiene (WASH) variables and their association with nutritional status of children under 24 months in rural Cambodia.DesignWe conducted surveys in 491 villages (clusters) randomised across 55 rural communes in Cambodia in September 2016 to measure associations between child, household and community-level risk factors for stunting and length-for-age z-score (LAZ). We measured 4036 children under 24 months of age from 3877 households (491 clusters). We analysed associations between nutrition/WASH practices and child growth (LAZ, stunting) using generalised estimating equations (GEEs) to fit linear regression models with robust SEs in a pooled analysis and in age-stratified analyses; child-level and household-level variables were modelled separately from community-level variables.ResultsAfter adjustment for potential confounding, we found household-level and community-level water, sanitation and hygiene factors to be associated with child growth among children under 24 months: presence of water and soap at a household's handwashing station was positively associated with child growth (adjusted mean difference in LAZ +0.10, 95% CI 0.03 to 0.16); household-level use of an improved drinking water source and adequate child stool disposal practices were protective against stunting (adjusted prevalence ratio (aPR) 0.80, 95% CI 0.67 to 0.97; aPR 0.82, 95% CI 0.64 to 1.03). In our age-stratified analysis, we found associations between child growth and community-level factors among children 1-6 months of age: shared sanitation was negatively associated with growth (-0.47 LAZ, 95% CI -0.90 to -0.05 compared with children in communities with no shared facilities); improved sanitation facilities were protective against stunting (aPR 0.43, 95% CI 0.21 to 0.88 compared with children in communities with no improved sanitation facilities); and open defecation was associated with more stunting (aPR 2.13, 95% CI 1.10 to 4.11 compared with children in communities with no open defecation). These sanitation risk factors were only measured in the youngest age strata (1-6 months). Presence of water and soap at the household level were associated with taller children in the 1-6 month and 6-12 month age strata (+0.10 LAZ, 95% CI -0.02 to 0.22 among children 1-6 months of age; +0.11 LAZ, 95% CI -0.02 to 0.25 among children 6-12 months of age compared with children in households with no water and soap). Household use of improved drinking water source was positively associated with growth among older children (+0.13 LAZ, 95% CI -0.01 to 0.28 among children 12-24 months of age).ConclusionIn rural Cambodia, water, sanitation and hygiene behaviours were associated with growth faltering among children under 24 months of age. Community-level sanitation factors were positively associated with growth, particularly for infants under 6 months of age. We should continue to make effort to: investigate the relationships between water, sanitation, hygiene and human health and expand WASH access for young children.

Project description:BackgroundCholera remains a substantial health burden in Asia and Africa particularly in resource poor settings. The standard procedures to identify the etiological organism V. cholerae are isolation from microbiological culture from stool as well as Polymerase Chain Reaction (PCR). Both the processes are highly lab oriented, labor extensive, time consuming, and expensive. In an effort to control for outbreaks and epidemics; an effective, convenient, quick and relatively less expensive detection method is imperative, without compromising the sensitivity and specificity that exists at present. The objective of this component of the study was to evaluate the effectiveness of a locally produced rapid diagnostic test (RDT) for cholera diagnosis.MethodsIn Bangladesh, nationwide cholera surveillance is ongoing in 22 hospitals covering all 8 divisions of the country since June, 2016. In the surveillance, stool samples have been collected from patients presenting to hospitals with acute watery diarrhea. Crystal VCTM (Span diagnostics, India) and Cholkit (locally produced RDT) have been used to detect V. cholerae from stool samples. Samples have also been sent to the main laboratory at icddr,b where the culture based isolation is routinely performed. All the tests were carried out for both direct and enriched stool samples. RDT sensitivity and specificity were calculated using stool culture as the gold standard.ResultsA total of 7720 samples were tested. Among these, 5865 samples were solely tested with Crystal VC and 1355 samples with Cholkit whereas 381 samples were tested with both the RDTs. In comparison with culture, direct testing with Crystal VC showed a sensitivity of 72% (95% CI: 50.6% to 87.9%) and specificity of 86.8% (95% CI: 82.8% to 90.1%). After enrichment the sensitivity and specificity was 68% (95% CI: 46.5% to 85.1%) and 97.5% (95% CI: 95.3% to 98.8%) respectively. The direct Cholkit test showed sensitivity of 76% (95% CI: 54.9% to 90.6%) and specificity of 90.2% (95% CI: 86.6% to 93.1%).ConclusionThis evaluation has demonstrated that the sensitivity and specificity of Cholkit is similar to the commercially available test, Crystal VC when used in field settings for detecting V. cholerae from stool specimens. The findings from this study suggest that the Cholkit could be a possible alternative for cholera endemic regions where V. cholerae O1 is the major causative organism causing cholera.

Dataset Information

Randomised controlled trial to test the effectiveness of a locally-produced ready-to-use supplementary food (RUSF) in preventing growth faltering and improving micronutrient status for children under two years in Cambodia: a study protocol.

Publications

Randomised controlled trial to test the effectiveness of a locally-produced ready-to-use supplementary food (RUSF) in preventing growth faltering and improving micronutrient status for children under two years in Cambodia: a study protocol.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets