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

Bindi Borg, Seema Mihrshahi, Mark Griffin, Daream Sok, Chamnan Chhoun, Arnaud Laillou, Jacques Berger, Frank T Wieringa, Bindi Borg, Seema Mihrshahi, Mark Griffin, Daream Sok, Chamnan Chhoun, Arnaud Laillou, Jacques Berger, Frank T Wieringa

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 .

Keywords: Cambodia; Childhood malnutrition; Corn-Soy Blend Plus Plus (CSB++); Growth faltering; Lipid-based nutrient supplement (LNS); Ready-to-use supplementary food (RUSF); Sprinkles micronutrient powders; Supercereal Plus.

Conflict of interest statement

Ethics approval and consent to participate

Ethics approval was received from the University of Queensland Medical Research Ethics Committee (2014001070) and from Cambodia’s National Ethics Committee for Health Research (402 NECHR). Written informed consent will be obtained from all the caregivers or parents of the participating children before recruitment into the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Site selection, recruitment and enrolment of children

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