Benefits and Risks of Iron interventionS in Children (BRISC): a randomized controlled trial in Bangladesh

Background (brief): a. Burden: About 43% of pre-school children worldwide and 60% children 6-24 months of age in rural Bangladesh are anaemic and half of the burden of anaemia is assumed to be attributable to iron deficiency (ID) which may impair brain development in this critical period of life b. Knowledge gap: Though WHO recommends universal supplementation of either iron supplements or iron-containing multiple micronutrient powders (MMPs) to children under 2yrs to improve iron status, little is known about the effects of these supplementations on child’s developmental outcomes and infectious morbidity c. Relevance: The study will bring an opportunity to evaluate an immediate and long term effect of iron and MMPs supplementation at early childhood, which may form the platform for global anaemia control policy in young children. Hypothesis: Both universal iron supplementation and MMPs will improve cognitive development across the population, both immediately after intervention and after a further 9 months Objectives: Primary objective is to evaluate the impact of iron supplementation and MMPs on cognitive development in young children, compared with placebo, at end of intervention Secondary objectives are a) to determine the effects of universal iron supplementation and MMPs on other key functional outcomes i.e. language and motor development and behaviour and growth of children, both immediately following intervention and after 9 months follow up, b) to determine the adverse effects of universal iron supplementation and MMPs, especially morbidity from diarrhoea and respiratory infections, and c) to determine the effects of iron and MMPs on haematologic and iron indices and child growth. Methods: A three-arm, double-blind, placebo controlled RCT comparing daily (i) iron supplementation; (ii) MMPs; and (iii) placebo (double dummy) will be given for 03 months to children aged 8 months.. Detailed cognitive and clinical assessments at baseline, end of intervention (+3 months) and after a further 9 months (+12 months). Inclusion criteria: Children aged 8 months, without known inherited haematologic or developmental disorder or severe malnutrition, or who are exposed to high groundwater iron. Outcome measures/variables: Childs’s cognitive, motor and language development measured on Bayley-III, behaviour on Wolke’s rating scales, temperament, quality of home stimulation using family care indicators, growth measured by length, weight and head circumference, morbidity, socioeconomic status, direct and indirect cost and haemoglobin, ferritin and CRP.