The absorption of non-haem iron during suppression of gastric acid secretio
- Conditions
- hereditary hemochromatosisiron overload disease100198061001794310019654
- Registration Number
- NL-OMON41064
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
In order to be eligible to participate in this study, a hemochromatosis patient must meet all of the following criteria:
• Patients with hereditary hemochromatosis, homozygous for C282Y, with biochemical or liver biopsy proven iron overload in the past.
• Patients are currently on maintenance treatment of which the last treatment was more than six weeks ago.
• Ferritin levels for men and postmenopausal women should be < 400 ug/l and for premenopausal women <150 ug/l, for at least 3 months.
• Age: > 18 years, <=65;A healthy control must meet all the following criteria:
• Subjects do not have HFE mutations
• Age >18, <=65
• Ferritine levels for men and postmenopausal women should be < 400 ug/l and for premenopausal women <150 ug/l.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Patients/subjects with known acute or chronic inflammatory disorders, such as inflammatory bowel disease or rheumatoid arthritis, hepatitis B, hepatitis C or HIV infection
• Patients/subjects with cirrhosis of the liver
• Patients/subjects with excess alcohol ingestion (> 21 glasses a week for men, >14 glasses a week for women)
• Phlebotomy/erythrocytapharesis less than 6 weeks before participation in research
• Patients/subjects <18 years, and >65 years
• Patients/subjects with a malignancy
• Patients/subject who are anemic
• Patients/subjects already on PPI treatment
• Patients/subjects who experienced side effects of PPI*s
• Patients/subjects on different acid-suppressing medication (e.g. H2- blockers)
• Patients/subjects that use iron supplements
• Patients/subjects who are pregnant.
• Patients/subjects who use medication that interferes with PPI medication.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The course in hepcidin concentration, measured after an oral iron challenge,<br /><br>before and after gastric acid suppression in hemochromatosis patients and<br /><br>healthy controls will be the primary endpoint of the study.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoint is to prove the difference in increase of serum iron<br /><br>concentration, after oral iron challenge, before and after gastric acid<br /><br>suppression in hemochromatosis patients and healthy controls.</p><br>