Overview

Mi-iron is a research project which aims to measure the effect of reducing moderate iron overload back to the normal range in people with haemochromatosis. The only way to know for certain the effects of reducing moderate iron overload is to compare symptoms in people who have had their iron levels reduced (group 1), to those who have not had their iron levels reduced (group 2).  

This study will compare these two groups of people and measure improvement of symptoms such as fatigue, mood and general feeling of well-being.

What is Haemochromatosis?

Information for participants

Mi-iron recruited 110 participants from Victoria and Queensland. To take part in this study, a participants needed to meet the following criteria:

1. Diagnosed with haemochromatosis due to having two copies of the same HFE gene fault called C282Y.
2. Aged 18 - 70 years.
3. Have moderate iron overload (serum ferritin between 300ug/L - 1000ug/L, see table below)
4. Have no other major diseases or risk factors such as liver disease, excess alcohol consumption, body mass index (BMI) >35.
5. Has not received venesection therapy for haemochromatosis in the last two years.

Table 1. Body iron levels are determined by the amount of Serum Ferritin (SF) in the body. Table 1 shows SF ranges for normal, moderate and high iron levels. People with moderate levels of iron are eligible to take part in Mi-iron.

Important Serum Ferritin reference ranges

Research team

Mi-iron is a collaborative study between the Murdoch Children's Research Institute, Austin Health, Royal Melbourne Hospital and Royal Brisbane and Women's Hospital.

Research

How were participants' iron levels be reduced?

Usually, treatment for high levels of iron caused by haemochromatosis involves the frequent removal of blood until the amount of iron is reduced to normal levels. This treatment is called venesection or phlebotomy.

To be as certain as possible that any change in symptoms is because of the reduction in iron levels, it is important that the people taking part in the research project were not aware of what group they are in and if their iron levels have been reduced. We devised a way of doing this by using a treatment called 'apheresis'.

People who were eligible to take part in the study were randomly allocated (like tossing a coin) to one of the two groups and when the apheresis treatment was done, they did not see the needle in the arm or the apheresis machine.

In apheresis, blood is removed from the arm and enters a machine. The machine removes the red blood cells (which contain iron) and then returns the blood to the body. Therefore, if red blood cells are removed and the fluid part of the blood is returned to the arm, body iron level will reduce (group 1). If the fluid part of the blood is removed and the red blood cells are returned to the arm, then the body iron levels will not be reduced (group 2). Following the study, those in group 2 will be offered apheresis or venesection at their choice of venue to have their iron levels reduced to normal.

This research project will compare symptoms in people who have had their iron levels reduced (group 1), to those who have not had their iron levels reduced (group 2). By asking participants to complete a questionnaire, have two blood tests and a liver ultrasound scan at the beginning and at the end of the study period. Importantly, this study will answer the question; how do we treat people with moderate iron overload?