Proton Pump Inhibitors in the Prevention of Iron Reaccumulation in Patient With Hereditary Hemochromatosis
Status:
Unknown status
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
Summary
Hereditary Hemochromatosis (HH) is a genetic disorder of iron metabolism, resulting in
excessive iron overload causing damage of different important organs like heart, liver,
pancreas and joints. Complications and symptoms can regress by intensive treatment reducing
the iron overload stores.Different genes have been identified playing a role in the
pathophysiology of iron overload. A clinically important HFE gene mutation is the C282Y,
located on chromosome 6. Phlebotomy is currently the standard therapy which consists of
removal of 500 ml whole blood weekly, representing a loss of 250 mg iron. In naive patients
between 20 to 100 phlebotomies are required to reduce the serum ferritine levels to 50 μg/L.
Thereafter, a lifelong maintenance therapy of 3 to 6 phlebotomies yearly is needed.
For absorption, dietary iron ( 70%) is reduced by gastric acid form the ferric (Fe3+) to the
ferrous form (Fe2+). Recently, in an observational open study, Hutchinson et al. found that
HH patients treated with proton pump inhibitors (PPI) needed fewer phlebotomies, resulting in
a drop of 2.5 (SEM 0.25) to 0.5 (SEM 0.25) liter per year.
Research question: The primary objective is to determine the effectiveness and cost
effectiveness of PPI's compared to standard phlebotomy therapy in the prevention of iron
overload in HH patients.
Multi-center trial in two hospitals in the South of Limburg (Atrium medical Center,
Maastricht university medical center ) and hospital in Belgium (University Hospital
Gasthuisberg). The study will be conducted in randomised double blind manner. The follow up
will be one year.
Patients are randomized either for the group receiving a PPI or a placebo. Every 2 month the
ferritin level is measured and decided if the patient need a phlebotomy (Ferritin >100 µg/L).