Effect of nutrition-improved wheat-based food on the health of primary school children aged 6-12 years in Morobe province

This study will be assessing the efficacy of micronutrient fortified biscuits on improving the nutrition status of children aged between 6 and 12 years in schools within the city of Lae. Two schools will be selected from urban Lae for the study, which is planned to commence at the end of January 2018 and conclude in June 2018 for 2 terms of the school year. This equates to approximately 100 school days. Following screening, enrolment, baseline assessment, deworming and allocation (randomised, stratified by age, and blocked by sex), each child will receive wheat flour-based biscuits. In the case of the 'Intervention Group', these biscuits will be fortified with food-grade vitamins and minerals. Specifically, thiamin mononitrate (Vit. B1), riboflavin (B2), nicotinamide (B3), folic acid (B9), cyanocobalamin (B12), retinyl palmitate (Vit. A), iron (ferrous fumarate), and zinc (zinc oxide). The recommended fortification level in wheat flour is provided below based on a per capita daily consumption of between 75-149g of wheat flour: Micronutrient (compound form) - concentration (microgram/g in wheat flour) Iron (Ferrous fumarate) - 60 microgram/g Vitamin A (Retinyl palmitate) - 3 microgram/g Zinc (Zinc oxide) - 80 microgram/g Folic Acid - 2.6 microgram/g Thiamine (Thiamine mononitrate) - 10 microgram/g Riboflavin - 2 microgram/g Niacin (Nicotinamide) - 130 microgram/g Vitamin B12 (Cyanocobalamin) - 0.02 microgram/g When formulating the biscuits for children, the targets for addition have been based on the lower end of the consumption range. Therefore, the dose of vitamins in each biscuit has been calculated to provide the equivalent intake as would be found in the daily consumption of 75g of fortified wheat flour, These figures will be: Micronutrient (compound form) - concentration (microgram/g in biscuit formulation) Iron (Ferrous fumarate) - 225.00 microgram/g Vitamin A (Retinyl palmitate) - 11.25 microgram/g Zinc (Zinc oxide) - 300 microgram/g Folic Acid - 9.75 microgram/g Thiamine (Thiamine mononitrate) - 37.5 microgram/g Riboflavin - 7.5 microgram/g Niacin (Nicotinamide) - 487.50 microgram/g Vitamin B12 (Cyanocobalamin) - 0.08 microgram/g Each child will receive one biscuit per day of attendance throughout the study period except school and public holidays. Biscuits will be provided to students by their school teachers, who will have been trained by the research team on allocation methods and compliance. Teachers will have access to a sheet linking students' identities to biscuit code allocations, but will be blind to which biscuits are intervention or control. Students will be called from a roll sheet by name to collect their biscuits from the teacher. Intervention fidelity will be assessed by means of spot checks by local researchers and assistants from the PNG University of Technology in Lae. Teachers will also be asked to record absentees, and reasons for absenteeism. This will assist in post-trial association between intervention and morbidity throughout the course of the intervention. Researchers and assistants will also be blinded to intervention product code identities throughout the trial from allocation to after statistical analysis (by means of an academic statistician otherwise unaffiliated with our project, from the School of Public Health & Community Medicine at UNSW Sydney), so privacy and research fidelity will likewise be secure from the researcher side during spot-checking activities. Deworming treatment will be provided to all participants at the time of baseline assessment when biological sample collection and assessments are being taken. This treatment will be in the form of a single 400mg tablet dose of Albendazole administered by trained nurses. Albendazole is effective on Hookworm, Roundworm and Whipworm soil transmitted helminth (STH) infections common in PNG, and is recommended by the World Health Organization for use in Mass Drug Administration (MDA) programs.