Ignite Creation Date:
2024-05-06 @ 12:15 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01524757
Status:
UNKNOWN
Last Update Posted:
2012-02-02
First Post:
2012-01-31
Brief Title:
Proton Pump Inhibitors in the Prevention of Iron Reaccumulation in Patient With Hereditary Hemochromatosis
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Proton Pump Inhibitors in the Prevention of Iron Reaccumulation in Patient With Hereditary Hemochromatosis
Status:
UNKNOWN
Status Verified Date:
2012-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
He-ppi
Brief 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 storesDifferent 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 μgL 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 25 SEM 025 to 05 SEM 025 liter per year
Research question The primary objective is to determine the effectiveness and cost effectiveness of PPIs 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 µgL
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 25 SEM 025 to 05 SEM 025 liter per year
Research question The primary objective is to determine the effectiveness and cost effectiveness of PPIs 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 µgL
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None