Chicken liver and eggshell crackers as a safe and affordable animal-source food for overcoming micronutrient deficits during pregnancy and lactation in Indonesia: a double-blind randomised controlled trial
Wellcome Trust
SEAMEO Regional Center for Food and Nutrition
A double-blind two-phase cluster randomized controlled trial will be conducted in West Java, Indonesia. Total 308 pregnant women will be recruited from 28 clusters (villages) in Sumedang district. Women who fulfil trial criteria will be randomly selected and invited into the trial. Clusters will be randomly assigned to receive placebo or micronutrient-enriched crackers (MEC) daily, distributed by cadres from 14 weeks to 5 months post-partum. Placebo and intervention crackers (recipe developed from chicken liver and eggshell by Food Scientists at University of Otago and pre-tested for acceptability) will be manufactured locally so they are identical in size, colour, and packaging, with a code known only by the local production manager who will not share the code until the primary outcome has been analysed statistically. Primary outcomes will be birth length and infant linear growth (attained and incremental). Secondary outcomes will be: (a) birth weight; (b) maternal haemoglobin at 37 weeks gestation; (c) volume and breastmilk micronutrient concentrations at 5 months post-partum; (d) maternal dietary intakes at 37 weeks and 5 months post-partum; (e) maternal micronutrient status at 37 weeks and 5 months post-partum; (f) micronutrient status of breastfeeding infants at aged 5 months. Analysis will be by intention to treat.
6.1 Pharmaceuticals