A novel nano-iron supplement versus standard treatment for iron deficiency anaemia in children 6–35 months (IHAT-GUT trial): a double-blind, randomised, placebo-controlled non-inferiority phase II trial in The Gambia
Nuredin Mohammed, James Wason, Thomas Mendy, Stefan A. Nass, Ogochukwu Ofordile, Famalang Camara, Bakary Baldeh, Chilel Sanyang, Amadou T. Jallow, Ilias Hossain, Nuno Faria, Jonathan J. Powell, Andrew M. Prentice, Dora I. A. Pereira
Abstract
Background: Iron deficiency anaemia (IDA) is the leading cause of years lost to disability in most sub-Saharan African countries and is especially common in young children. The IHAT-GUT trial assessed the efficacy and safety of a novel nano iron supplement, which is a dietary ferritin analogue termed iron hydroxide adipate tartrate (IHAT), for the treatment of IDA in children under 3 years of age. Methods: and the estimated dose with comparable iron-bioavailability for IHAT (20 mg Fe). The primary efficacy endpoint was the composite of haemoglobin response at day 85 and correction of iron deficiency. The non-inferiority margin was 0.1 absolute difference in response probability. The primary safety endpoint was moderate-severe diarrhoea analysed as incidence density and prevalence over the 3 months intervention. Secondary endpoints reported herein include hospitalisation, acute respiratory infection, malaria, treatment failures, iron handling markers, inflammatory markers, longitudinal prevalence of diarrhoea and incidence density of bloody diarrhoea. Main analyses were per-protocol (PP) and intention-to-treat (ITT) analyses. This trial is registered with clinicaltrials.gov (NCT02941081). Findings: group and 37 (30.1%) cases in the placebo group. Interpretation: , with no increased adverse events in comparison with placebo. Funding: The Bill & Melinda Gates Foundation (OPP1140952).