A double blind randomised controlled trial comparing standard dose of iron supplementation for pregnant women with two screen-and-treat approaches using hepcidin as a biomarker for ready and safe to receive iron

What this study found

Aim to determine whether a hepcidin-guided screen-and-treat approach yields non-inferior haemoglobin at Day 84 compared with universal 60 mg/day iron (non-inferiority margin 0.5 g/dL). Secondary endpoints include adverse effects, compliance and infection susceptibility. If non-inferior, this approach could reduce total iron exposure and side effects and support use of hepcidin as a point-of-care diagnostic to guide iron therapy in pregnancy.

Study & population

3-arm, double-blind randomized controlled trial; 462 healthy pregnant women aged 18-45 years; rural Gambia (Kiang West and Kiang East); enrollment within 14–22 weeks gestation; baseline haemoglobin measured; exclusions: severe anaemia (<7 g/dL) or serious illness; randomization by predetermined blocks; blinding maintained for participants, field workers,…

Intervention

Arm A: UNIMMAP containing 60 mg iron per day for 12 weeks; 1 capsule daily; weekly 7-day supply.

Key limitation

Not powered to assess clinical safety endpoints; safety assessed with in vitro assays; 12-week duration may miss longer-term effects; conducted in rural Gambia, limiting generalizability.

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