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

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, nursing staff and investigators; follow-up for 12 weeks; primary endpoint haemoglobin at Day 84.

Arm A: UNIMMAP containing 60 mg iron per day for 12 weeks; 1 capsule daily; weekly 7-day supply. Arm B: UNIMMAP containing 60 mg iron per day for 12 weeks; dosing occurs in weekly 7-day blocks guided by weekly hepcidin testing; 7-day iron dosing when hepcidin < 2.5 ng/mL, otherwise 0 mg for that block. Arm C: UNIMMAP containing 30 mg iron per day for 12 weeks; 1 capsule daily; weekly 7-day supply.

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.

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.