LEAP-1: Lactoferrin Evaluation in Anemia in Pregnancy

Project type/s Clinical trial
Project status Currently underway

Iron deficiency is the most common nutritional disorder in the world and a global public health crisis affecting over 2 billion people (WHO 2008), with women and children at greatest risk.
Iron is vital for fetal growth, especially early brain growth and function. Iron deficiency and iron deficiency anaemia are linked with low birth weight, preterm birth, fetal growth restriction (small for gestational age), neonatal mortality, stillbirth and reduced iron status in mother and infant which, in turn, is associated with impaired mother-infant interactions, irreversible psychomotor delay, lower IQ, behaviour problems and poor school performance. Prenatal ID and impaired fetal growth also predispose to obesity, diabetes mellitus and hypertension.

A Cochrane Review of 23 RCTs in IDAP in 3,198 women (mean trial size =139) found that oral iron reduced maternal anaemia but that no trials reported clinical outcomes in children. The authors therefore concluded it was unclear if treating mild or moderate anaemia achieves net benefit and recommended larger trials of different treatments with major outcomes, stratified by severity of anaemia.

Oral inorganic iron salts, such as ferrous sulphate (FeSO4), are standard treatment in IDAP but poorly tolerated. Up to 82% of Australian women with IDAP had nausea, abdominal pain, or constipation on daily FeSO4.

Lactoferrin (LF) is an iron-carrying, immunomodulatory, anti-inflammatory, antioxidant, bifidogenic glycoprotein found in vertebrates and mammalian white blood cells, mucosa, secretions and milk. It is a key element of the innate immune response and modulates inflammation and iron homeostasis. We and others have shown that bLF improves ID, both as an iron supplement and also indirectly by regulating iron homeostasis and inflammation.

Lactoferrin in Anaemia of Pregnancy (LEAP1) is a multicentre trial which aims to evaluate the effects of treatment with standard oral iron versus oral bovine lactoferrin (bLF) in women with iron deficiency anaemia in pregnancy (IDAP). 800 women with mild/moderate iron deficiency anaemia with pregnancy <30 weeks and >12 weeks will be randomly assigned to either ferrous sulphate or bLF.

Team Members

  • Josephine Laurie - Team Role: Principal Investigator
  • Chloe Pullar - Team Role: Other (Mater Sponsor / Mater Contact)
  • Lucinda Harris-Hughes - Team Role: Other (Mater Sponsor / Mater Contact)