The trial, which has just received funding from Bill and Melinda Gates Foundation, USAID, the Norwegian Government, Grand Challenges Canada, and UK AID, is part of an international effort led by the University of Sydney to protect hundreds of Bangladeshi newborns from a host of severe health problems.
Professor Michael Dibley of the University of Sydney, leader of the trial to be conducted in Bangladesh, commented on the impact the trial could have if successful.
"Lactoferrin could prove to be a cheap and accessible way to rapidly reverse some of the ill effects of iron deficiency that affect two billion people globally," said Professor Dibley.
A component of the human immune system, lactoferrin also has antiviral, antibacterial, antifungal, anti-inflammatory and anti-carcinogenic properties.
The nature of the problem
Iron deficiency in pregnancy affects more than 50 per cent of women in low-income countries, 12 per cent in Australia and the UK, and in 25 to 40 per cent in Aboriginal and other disadvantaged groups of women.
Often pregnant women will develop iron deficiency anemia due to the increased iron requirements of a growing fetus, and the higher volume of blood circulating in a woman's body during pregnancy.
Lactoferrin is an iron-binding protein that may rapidly restore natural iron levels and assist in the prevention of iron deficiency - a risk factor for anemia that poses health risks to a developing fetus. These risks may include impaired fetal growth, premature birth, low birth weight and higher rates of neonatal death.
Additionally, Anemia during pregnancy could predispose newborns to future problems, such as irreversible psychomotor delay, behavioural and school problems, low intelligence, obesity, hypertension and diabetes.
How the research trial will be run
University of Sydney Professor of Neonatology, Professor William Tarnow-Mordi explained how the research would be conducted.
"Our trial in Bangladesh, which starts shortly, will initially compare lactoferrin with ferrous sulphate - both in oral capsule form - in iron-deficient anemic, non-pregnant women," said Professor Tarnow-Mordi.
"Iron sulphate is currently the standard first line of defense against anemia but it is suboptimal and has a host of negative side effects. For example, it is poorly absorbed, causes inflammatory problems, and poses a risk of accidental overdose and death in children if not safely stored."
If Lactoferrin proves to be as safe and effective as iron sulphate, the trial will proceed to a second stage comparing lactoferrin with (i) ferrous sulphate and (ii) lactoferrin supplemented with vitamin A and riboflavin for the treatment of iron deficient, anemic pregnant women. A third stage of the trial will compare lactoferrin with iron sulphate on birth outcomes.
Scaling the benefits
The Bangladeshi trial is a collaboration between the NHMRC Clinical Trials Centre, the WINNER Centre for Newborn Research, the Sydney School of Public Health, the International Centre for Diarrhoeal Disease Research, Bangladesh and BRAC, a development organisation that alleviates poverty by assisting poor people to create change in their own lives.
Professor Dibley explained what the next steps would be if the treatment was proven to be successful.
"If the trial is effective, we will be working with our partners in Bangladesh and other regions in Asia and in Australia, New Zealand and Europe to raise the availability of lactoferrin," said Professor Dibley.
"To do this sustainably in Asian countries will mean scaling up the milk production capacity of those countries. This offers enormous benefits in terms of research and development, skills infrastructure capacity building, and employment."
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