Crossover trial to test the acceptability of a locally produced lipid-based nutrient supplement (LNS) for children under 2 years in Cambodia: a study protocol

BMJ Open. 2017 Sep 6;7(9):e015958. doi: 10.1136/bmjopen-2017-015958.

Abstract

Introduction: The acceptability and efficacy of existing ready-to-use supplementary and therapeutic foods has been low in Cambodia, thus limiting success in preventing and treating malnutrition among Cambodian children. In that context, UNICEF and IRD have developed a locally produced, multiple micronutrient fortified lipid-based nutrient supplement. This food is innovative, in that it uses fish instead of milk as the animal source food. Very few supplementary foods have non-milk animal source foods, and in addition they have not been widely tested. This trial will assess the novel food's acceptability to children and caregivers.

Methods and analysis: This is a cluster-randomised, incomplete block, 4×4 crossover design with no blinding. It will take place in four sites in a community setting in periurban Phnom Penh. Healthy children aged 9-23 months (n=100) will eat each of four foods for 3 days at a time. The amount they consume will be measured, and at the end of each 3-day set, caregivers will assess how well their child liked the food. After 12 days, caregivers themselves will do a sensory test of the 4 foods and will rank them in terms of preference.

Ethics and dissemination: Ethical clearance was received from the University of Queensland Medical Research Ethics Committee (2014001070) and from Cambodia's National Ethics Committee for Health Research (03/8 NECHR).

Registration: ClinicalTrials.gov, identifier: LNS-CAMB-INFANTS; NCT02257437. Pre-results.

Keywords: Lipid-based nutrient supplement (LNS); acceptability; hedonic scale; micronutrient powder; ready-to-use supplementary food (RUSF); test feeding.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Anthropometry
  • Cambodia
  • Child Development
  • Cross-Over Studies
  • Dietary Fats*
  • Dietary Supplements*
  • Female
  • Humans
  • Infant
  • Male
  • Malnutrition / prevention & control*
  • Regression Analysis
  • Research Design
  • Seafood*

Substances

  • Dietary Fats

Associated data

  • ClinicalTrials.gov/NCT02257437