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Hepcidin and Anaemia in Pregnancy (HAPn)

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN21955180
Enrollment
462
Registered
2014-04-14
Start date
2014-04-21
Completion date
Unknown
Last updated
2019-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaemia in pregnancy Pregnancy and Childbirth

Interventions

This study will involve 462 pregnant women between 14 and 22 weeks gestation over a period of 12 weeks randomly assigned (1:1:1 ratio) to either receive: 1. UNIMMAP containing 60 mg/da

Sponsors

The Medical Research Council (MRC) (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Pregnant (gestational age between 14 - 22 weeks) 2. Age: 18 to 45 years 3. Likely to be resident in study area for duration of trial 4. Written informed consent obtained

Exclusion criteria

Exclusion criteria: 1. Severely anaemic (< 7 g/dl) 2. Seriously ill (infectious disease of clinical significance) at recruitment 3. Chronic disease 4. Pregnancy complications (e.g. pre-eclampsia) at enrolment 5. Already part of another study

Design outcomes

Primary

MeasureTime frame
Haemoglobin - defined as pregnancy stage adjusted haemoglobin at day 84

Secondary

MeasureTime frame
1. Proportion of anaemia (Hb < 11 g/dl) at day 84 2. Iron deficiency prevalence at day 84 3. Iron deficiency anaemia (IDA) prevalence at day 84 4. Iron dosage 5. Beneficial and adverse events 6. Compliance

Countries

Gambia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 12, 2026