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Background:  Iron deficiency and its associated anaemia (IDA) are the leading forms of micronutrient malnutrition worldwide. Conventional oral iron supplements have limited efficacy and have been associated with increased infection, diarrhoea, and detrimental changes to the gut microbiome, particularly in young children. Here we describe the rationale and design of the first clinical trial evaluating the efficacy and safety of a novel nano iron supplement, iron hydroxide adipate tartrate (IHAT), for the treatment of IDA in young children (IHAT-GUT trial).    Methods:  IHAT-GUT is a three-arm, double-blind, randomised, placebo-controlled trial conducted in Gambian children 6-35 months of age. The intervention consists of a 12-week supplementation with either IHAT, ferrous sulphate (both at doses bioequivalent to 12.5 mg Fe /day) or placebo. Assessments are conducted at baseline, Day 15, and Day 85 of the supplementation period. The trial aims to include 600 children with IDA who will be randomly assigned (1:1:1) to each arm. The primary objectives are to test non-inferiority of IHAT in relation to ferrous sulphate at treating IDA, and to test superiority of IHAT in relation to ferrous sulphate and non-inferiority in relation to placebo in terms of diarrhoea incidence and prevalence. Secondary objectives are to test whether IHAT reduces the burden of enteric pathogens, morbidity, and intestinal inflammation, and that it does not cause detrimental changes to the gut microbiome, particularly in relation to  Lactobacillaceae ,  Bifidobacteriaceae  and  Enterobacteriaceae .    Discussion:  This trial will test the hypothesis that supplementation with IHAT eliminates iron deficiency and improves haemoglobin levels without inducing gastrointestinal adverse effects. If shown to be the case, this would open the possibility for further testing and use of IHAT as an alternative iron source for micronutrient intervention strategies in resource-poor countries, with the ultimate aim to help reduce the IDA global burden.    Registration:  This trial is registered at clinicaltrials.gov ( NCT02941081 ).

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A novel nano-iron supplement to safely combat iron deficiency and anaemia in young children: The IHAT-GUT double-blind, randomised, placebo-controlled trial protocol