Proton Pump Inhibitors in the Prevention of Iron Reaccumulation in Patient With Hereditary Hemochromatosis (He-ppi)
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Proton Pump Inhibitors in the Prevention of Iron Reaccumulation in Patient With Hereditary Hemochromatosis|
- the total number of phlebotomies for the group taking PPI treatment compared to the group taking placebo will be the primary endpoint of the study. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- number of participants with side effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
pantoprazole 40mg 1dd1; 12 months
|Placebo Comparator: placebo||
pantoprazole 40mg 1dd1; 12 months
|Contact: G Koek, email@example.com|
|Contact: C Deursen Van, firstname.lastname@example.org|
|University hospital Gasthuisberg||Not yet recruiting|
|Leuven, Limburg, Belgium, 3000|
|Contact: David Cassiman, prof. dr. +32 16344626 email@example.com|
|Principal Investigator: David Cassiman, prof. dr.|
|Atrium MC Parkstad||Not yet recruiting|
|Heerlen, Limburg, Netherlands, 6440 AG|
|Contact: Cees Deursen, dr +31-45-5279639 firstname.lastname@example.org|
|Contact: Reggy Jaspers, drs +31-43-3875021 r.jaspers@Mumc.nl|
|Principal Investigator: C Deursen, dr|
|Maastricht university medical center||Not yet recruiting|
|Maastricht, Limburg, Netherlands, 6202AZ|
|Contact: Reggy Jaspers, drs +31-43-3875021 email@example.com|
|Contact: Ger Koek, dr- +31-43-3875021 firstname.lastname@example.org|
|Principal Investigator: Ger Koek, dr|
|Principal Investigator:||G Koek, Dr||Maastricht University Medical Center|