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

February 1, 2012 updated by: Maastricht University Medical Center

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Limburg
      • Leuven, Limburg, Belgium, 3000
        • University Hospital Gasthuisberg
        • Contact:
        • Principal Investigator:
          • David Cassiman, prof. dr.
  • Netherlands
    • Limburg
      • Heerlen, Limburg, Netherlands, 6440 AG
        • Atrium MC Parkstad
        • Contact:
        • Contact:
        • Principal Investigator:
          • C Deursen, dr
      • Maastricht, Limburg, Netherlands, 6202AZ
        • Maastricht University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ger Koek, dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
number of participants with side effects
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Annadal stichting

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

January 31, 2012

First Submitted That Met QC Criteria

February 1, 2012

First Posted (Estimate)

February 2, 2012

Study Record Updates

Last Update Posted (Estimate)

February 2, 2012

Last Update Submitted That Met QC Criteria

February 1, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL3364409612

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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