Ontology highlight
ABSTRACT: Introduction
Anaemia is a major global health problem affecting about 43% of preschool children globally and 60% of 6-24-month-old children in rural Bangladesh, half of which is attributed to iron deficiency (ID). Although WHO recommends universal supplementation with iron or home fortification with iron-containing multiple micronutrient powders (MMPs) to children under 2 years, evidence for benefits of these interventions on childhood development (a key rationale for these interventions) and harms (especially infection) remains limited. This study aims to evaluate the impact of iron or MMPs supplementation compared with placebo on (a) children's development, (b) growth, (c) morbidity from infections and (d) haematological and iron indices.Methods and analysis
This study is a three-arm, blinded, double-dummy, parallel-group, placebo-controlled superiority trial using stratified individual block randomisation. The trial will randomise 3300 children aged 8-9 months equally to arm 1: iron syrup (12.5?mg elemental iron), placebo MMPs; arm 2: MMPs (including 12.5?mg elemental iron), placebo syrup; and arm 3: placebo syrup, placebo MNPs. Children will receive interventions for 3 months based on WHO recommendations and then be followed up for 9 months post intervention. The primary outcome is cognitive composite score measured by Bayley III. Secondary outcomes include motor and language composite score by Bayley III, behaviour rating using selected items from Wolke's rating scales and BSID-II behaviour ratings, temperament, growth, haemoglobin, anaemia and iron status, and infectious morbidity. Outcomes will be measured at baseline, at the end of 3-month intervention and after 9 months postintervention follow-up.Ethics and dissemination
The trial has been approved by the Ethical Review Committee of icddr,b (Dhaka, Bangladesh) and the Melbourne Health Human Research Ethics Committee (Melbourne, Australia). Results of the study will be disseminated through scientific publications, presentations at international meetings and policy briefs to key stakeholders.Trial registration number
ACTRN12617000660381;Pre-results.Who universal trial number
U1111-1196-1125.
SUBMITTER: Hasan MI
PROVIDER: S-EPMC5695407 | biostudies-literature | 2017 Nov
REPOSITORIES: biostudies-literature
Hasan Mohammed Imrul MI Hossain Sheikh Jamal SJ Braat Sabine S Dibley Michael John MJ Fisher Jane J Grantham-McGregor Sally S Tofail Fahmida F Simpson Julie A JA Arifeen Shams Ei SE Hamadani Jena J Biggs Beverley-Ann BA Pasricha Sant-Rayn SR
BMJ open 20171115 11
<h4>Introduction</h4>Anaemia is a major global health problem affecting about 43% of preschool children globally and 60% of 6-24-month-old children in rural Bangladesh, half of which is attributed to iron deficiency (ID). Although WHO recommends universal supplementation with iron or home fortification with iron-containing multiple micronutrient powders (MMPs) to children under 2 years, evidence for benefits of these interventions on childhood development (a key rationale for these interventions ...[more]