Should we treat iron deficiency anaemia of pregnancy with lactoferrin? A randomised controlled trial Lactoferrin Evaluation in Anaemia in Pregnancy: LEAP-1

Should we treat iron deficiency anaemia of pregnancy with lactoferrin? A randomised controlled trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000988651

Acronym

LEAP-1

Enrollment

925

Registered

2014-09-15

Start date

2015-09-25

Completion date

2021-10-27

Last updated

2025-09-08

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

Conditions

None listed

Brief summary

Iron deficiency - the world’s commonest nutritional disorder affects over 2 billion people (WHO 2008), with women and children at greatest risk. This study aims to evaluate, in a randomised controlled trial (RCT), oral bovine lactoferrin (bLF) vs iron sulphate (FeSO4) in iron deficiency anaemia in pregnancy (IDAP). This study will comparerandomised groups on the following co-primary endpoints: 1) Fetal growth (birth weight for gestational age) 2) Whether oral bLF therapy reduces the proportion of women with IDAP who receive intravenous iron infusion according to standard protocol OR who do not respond to treatment and remain anaemic at any time between 34 weeks gestation and delivery.

Interventions

Bovine Lactoferrin 200 mg capsules once a day Duration of treatment: from enrolment (after 12 weeks gestation) until delivery; Adherence monitored via monthly questions on compliance.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Pregnant women with mild/moderate IDAP [Hb 70 -110 g/L] and gestation <30 weeks and >12 weeks OR Pregnant women likely to develop IDAP [Hb 111-115 g/L and serum ferritin <20micrograms/L ] and gestation <30 weeks and >12 weeks

Exclusion criteria

1. Contraindications to bLF or FeSO4 2. Severe anaemia needing intravenous iron according to local protocol (Hb <70 g/L) 3. Prior treatment with intravenous iron within 30 days 4. Any allergy to milk proteins or to iron products

Outcome results