The effect of milk thistle extract (Legalon) versus tea on serum iron increase after a meal containing non-haem iron in hereditary haemochromatosis

INTERVENTION: 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 descriptive name: SILYMARIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 140‐ Pharmaceutical form of the placebo: Oral liquid Route of administration of the placebo: Oral use CONDITION: 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 Classification code 10057873 Term: Hereditary haemochromatosis PRIMARY OUTCOME: 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. 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. 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. 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) ye