Type 1 hereditary haemochromatosis is associated with homozygous inheritance of the C282Y mutation in the HFE gene. The phenotype is characterised by increased serum iron levels, tissue iron accumulation and may result in liver fibrosis, cirrhosis, and liver carcinomas. Treatment initially involves removal of one unit of blood per week to remove body iron burden, then removal of one unit of blood 2-6 times per year to prevent the re-accumualtion of iron stores. MedDRA version: 8.1 Level: LLT
Conditions
Interventions
Trade Name: Legalon 140 mg (Legalon Forte)
Product Name: Legalon 140 mg (Legalon forte), Madaus GmbH, Germany
Pharmaceutical Form: Capsule*
INN or Proposed INN: SILYMARIN
CAS Number: 65666071
Other de
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (i) Patients will be homozygous for the C282Y mutation of the HFE gene (the genotype associated with type 1 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. (ii) 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. (iii) Patients will be adults (age 18+), as Type 1 hereditary haemochromatosis presents in adulthood. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (i) Patients with allergy to any foods or medicines will be excluded from participating for their own safety. (ii) 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. (iii) Patients with diabetes will be excluded from taking part in the study because of the requirement to fast prior to ingestion of the test meals.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to determine whether a milk thistle extract (Legalon), taken with a meal containing non-haem iron, leads to a reduction in serum iron increase following the meal.;Secondary Objective: The secondary objective of this study is to determine the effect of Legalon on serum iron increase following the meal, compared with a black tea beverage.;Primary end point(s): The primary end point of the trial is the increase in serum iron (as an estimate of iron absorption) after ingestion of a meal without Legalon / with Legalon / with tea. | — |
Countries
United Kingdom
Outcome results
None listed