Trial Summary:

The LEAP-1 study will evaluate the effects of treatment with oral bovine lactoferrin (bLF) versus iron sulphate (FeSO4) in iron deficiency anaemia in pregnancy (IDAP). Oral FeSO4 is the standard treatment for IDAP but it is poorly tolerated. IV or IM injections are alternatives, but they are costly and risk infection. bLF is a dairy protein classified by the FDA as Generally Recognised as Safe (GRAS). It is well established to mediate iron uptake from the gut with no side effects reported. A study in 60 women with IDAP showed bLF reduced anaemia and inflammation more effectively and was better tolerated than standard FeSO4.

This study aims to see if bLF administration during pregnancy improves foetal growth and neonatal iron status at birth compared to standard FeSO4.

Supported By:

NHMRC

Eligibility:

Women 18 years and older who are between 12 and 30 weeks gestation and have mild or moderate iron deficiency anaemia.

Registration ID:

ACTRN12614000988651

Participation:

A total of 900 women between 12 and 30 weeks gestation with mild or moderate iron deficiency anaemia.

Australian Lead Group:

NHMRC CTC

Status:

In follow-up

Activation Date:

17 September 2015

Chairs:

Prof William Tarnow-Mordi

Contact:

leap.study@sydney.edu.au