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The absorption of non-haem iron during suppression of gastric acid secretion

The absorption of non-haem iron during suppression of gastric acid secretion - The absorption of non-haem iron and gastric acid

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41064
Enrollment
20
Registered
2014-09-25
Start date
2015-01-05
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hereditary hemochromatosis iron overload disease

Interventions

After an overnight fast serum iron and hepcidin concentration will be determined. Healthy controls and hemochromatosis patients will then receive iron (Fe3+) polymaltose containing 50 mg of iron, th

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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 18 years, 18,

Exclusion criteria

Exclusion criteria: 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 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.

Design outcomes

Primary

MeasureTime frame
The course in hepcidin concentration, measured after an oral iron challenge, before and after gastric acid suppression in hemochromatosis patients and healthy controls will be the primary endpoint of the study.

Secondary

MeasureTime frame
The secondary endpoint is to prove the difference in increase of serum iron concentration, after oral iron challenge, before and after gastric acid suppression in hemochromatosis patients and healthy controls.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)