He-ppi: Proton Pump Inhibitors in the Prevention of Iron Reaccumulation in Patient With Hereditary Hemochromatosis

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01524757

Collaborator

Annadal stichting (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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 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).

Condition or Disease	Intervention/Treatment	Phase
Hemochromatosis	Drug: Pantoprazole	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Proton Pump Inhibitors in the Prevention of Iron Reaccumulation in Patient With Hereditary Hemochromatosis

Study Start Date :

Mar 1, 2012

Anticipated Primary Completion Date :

Aug 1, 2013

Anticipated Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pantoprazol	Drug: Pantoprazole pantoprazole 40mg 1dd1; 12 months
Placebo Comparator: placebo	Drug: Pantoprazole pantoprazole 40mg 1dd1; 12 months

Arm

Intervention/Treatment

Experimental: pantoprazol

Drug: Pantoprazole

pantoprazole 40mg 1dd1; 12 months

Placebo Comparator: placebo

Drug: Pantoprazole

pantoprazole 40mg 1dd1; 12 months

Outcome Measures

Primary Outcome Measures

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. [12 months]

Secondary Outcome Measures

number of participants with side effects [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with hereditary hemochromatosis (HH), homozygous for C282Y, currently treated with phlebotomy as maintenance therapy for at least 12 months with ≥ 3 phlebotomies per year.
Ferritin level between 50-100 μg/L at start of the inclusion.
Age: 18 years- 60 years and weight > 50 kg.

Exclusion Criteria:

Patients receiving other therapies such as chelating therapy or forced dietary regimen.
Patients younger than 18 years.
HH patients with excessive overweight (BMI > 35).
Patients who are mentally incapacitated.
Women being pregnant or expecting/ planning to become pregnant during the one year period of the study.
Patients with a malignancy.
Patients already on PPI treatment.
Patients who experienced side effects of PPI's.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University hospital Gasthuisberg	Leuven	Limburg	Belgium	3000
2	Atrium MC Parkstad	Heerlen	Limburg	Netherlands	6440 AG
3	Maastricht university medical center	Maastricht	Limburg	Netherlands	6202AZ

Sponsors and Collaborators

Maastricht University Medical Center
Annadal stichting

Investigators

Principal Investigator: G Koek, Dr, Maastricht University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Maastricht University Medical Center

ClinicalTrials.gov Identifier:

NCT01524757

Other Study ID Numbers:

NL3364409612

First Posted:

Feb 2, 2012

Last Update Posted:

Feb 2, 2012

Last Verified:

Jan 1, 2012

Additional relevant MeSH terms:

Hemochromatosis

Hemosiderosis

Pantoprazole

Study Results

No Results Posted as of Feb 2, 2012