Mi-Iron - Moderately Increased Iron - is Reducing Iron Overload Necessary?
There is mounting evidence that treatment of moderate iron overload in HFE related
hereditary haemochromatosis (HH) is not necessary. This project aims to undertake a
randomised patient-blinded trial of erythrocytapheresis compared to sham erythrocytapheresis
(using plasmapheresis) in individuals who have serum ferritin (SF) above the upper limit of
the normal range but < 1000ug/L (defined here as moderate iron overload) due to HFE
mutations and to compare the prevalence of symptoms and objective markers of disease in the
two treatment arms.
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Modified Fatigue Impact Scale (MFIS). The MFIS is a shortened version of the Fatigue Impact Scale. This 21-item scale can be self completed and measures the impact of fatigue on physical, cognitive and psychosocial functioning. Each item is scored from 0 (never) to 4 (almost always) resulting in a score from 0-84. In addition, physical (0-36), cognitive (0-40) and psychosocial (0-8) subscale scores can be derived.
Clinically and statistically significant change in measures taken at baseline and at the end of treatment will be compared. Patients will have approximately 6 third weekly treatments however this will vary depending on initial SF.
Martin B Delatycki
Austin Health/Murdoch Childrens Research Institute
Australia: Human Research Ethics Committee