Hereditary Haemochromatosis (HH) Nutritional, Metabolic, Endocrine Hereditary Haemochromatosis (HH)
Conditions
Interventions
The treatment intervention will consist of Legalon 140 mg (Madaus GmbH, Germany) milk thistle extract on one occasion with test meal. The comparator intervention will be a tea beverage on one occasion
Sponsors
King's College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients will be homozygous for the C282Y mutation of the HFE gene (the genotype associated with type one hereditary haemochromatosis), and have phenotypic haemochromatosis (identified by raised serum iron levels on diagnosis), as this is the particular group of interest which may benefit from interventions to reduce dietary iron absorption 2. ALL patients will be fully treated (i.e. undergoing phlebotomy to maintain iron stores within the normal range, following on from the removal of primary iron burden at diagnosis), in order to reduce variability in the data as iron absorption varies between fully treated and untreated/newly diagnosed patients 3. Patients will be adults (aged 18 or over), as type one hereditary haemochromatosis presents in adulthood
Exclusion criteria
Exclusion criteria: 1. Patients with allergy to any foods or medicines will be excluded from participating for their own safety 2. Patients with gastrointestinal diseases which alter gut motility, gut permeability or gastric pH (ulcerative colitis, Crohn's disease, coeliac disease, gastric ulceration) will also be excluded from participating as these disorders affect gastrointestinal function and, thus, may result in altered iron absorption and confound the results of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum iron increase after the test meal on each of three occasions (meal with milk thistle, versus meal with tea, versus meal with water). | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed