Objectives
Provision of iron in areas with a high prevalence of iron deficiency and widespread infection can cause serious adverse effects. We aimed to evaluate a hepcidin-screening-based iron supplementation intervention using a hepcidin cut-off of 5.5ng/mL designed to indicate that an individual requires iron and is safe to receive it.
Methods
We performed a proof-of-concept, three-arm, double-blind, randomized, controlled, parallel-group non-inferiority trial in 407 apparently healthy Gambian children, aged 6-23mo with haemoglobin concentration between 7 and 11g/dL. They were randomized to receive 12wks of multiple micronutrient powders containing: A) 12mg iron daily; B) 12mg or 0mg iron daily based on a weekly hepcidin screening indicating if iron can be given for the next seven days or not; C) 6mg or 0mg iron as in B).
Results
At 12wk mean haemoglobin differences [98.3% CI] between screen-and-treat at 12mg and 6mg compared to universal supplementation were -0.56 [-0.98, -0.13] and -0.77 [-1.20, -0.34] g/dL, respectively, not demonstrating non-inferiority. Proportion of anaemia, iron deficiency and iron deficiency anaemia were significantly higher in the screen-and-treat groups compared to the universal group at study end. Even in the universally supplemented group there was only a modest reduction in prevalence of anaemia from 91 to 77%.
Conclusions
A screen-and-treat approach using hepcidin at a cut-off of 5.5ng/mL to indicate whether it is safe to give iron is not non-inferior to universal supplementation. A supervised 12mg iron over 3mo according to WHO policy only results in a minimal reduction of anaemia prevalence.
