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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.

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.

journal_name

BMJ Open

journal_title

BMJ open

authors

Borg B,Mihrshahi S,Griffin M,Chamnan C,Laillou A,Wieringa FT

doi

10.1136/bmjopen-2017-015958

subject

Has Abstract

pub_date

2017-09-06 00:00:00

pages

e015958

issue

9

issn

2044-6055

pii

bmjopen-2017-015958

journal_volume

7

pub_type

杂志文章,多中心研究,随机对照试验

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