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

BackgroundExisting 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 analysisThis 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.DiscussionThere 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 registrationClinicalTrials.gov, Identifier: LNS-CAMB-INFANTS-EFF; NCT02257762.

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

“…The RUF could be either provided freely through nongovernmental organisation (NGO) programs or sold at the market. A middle model, which caregivers favour, would be for community health volunteers to sell RUF [44]. This kind of public/private production and distribution model should be explored further.…”

“…All groups continued to experience growth faltering, although the RUSF group faltered at a lower rate. Details on the effectiveness trial are described elsewhere [43], and results are forthcoming [44].…”

Effectiveness of a locally produced ready‐to‐use supplementary food in preventing growth faltering for children under 2 years in Cambodia: a cluster randomised controlled trial

“…Other researchers who have worked on small quantity LNSs (20‐50g/day) have found that in small quantities, LNSs may improve growth (Dewey et al, ; Hess et al, ). They may also improve appetite (Arimond et al, ; Lesorogol, Jean‐Louis, Green, & Iannotti, ), something which caregivers in our acceptability trial remarked upon (Borg et al, ). This finding warrants a trial of the RUSF in small quantities.…”

“…All processing was conducted in certified facilities, and microbiological safety testing was conducted regularly. The ingredients of the RUSF and the comparators are detailed in Tables A1 and A2, and in the acceptability and effectiveness protocols (Borg et al, ; Borg et al, ). The RUSF was provided as a medium quantity supplementary food, that is, providing 50‐100% of the child's daily energy requirements (i.e.…”

Interventions on Food Security and Water Uses for Improving Nutritional Status of Pregnant Women and Children Younger Than Five Years in Low-Middle Income Countries: A Systematic Review

“…Locally produced ready-to-use therapeutic food (RUTF) was also proven to be effective in preventing growth faltering and improving micronutrient status [19,20]. Nevertheless, according to Sigh et al, the provision of local foods combined with CEN did not improve young child nutritional status as compared to CEN alone.…”