Contact information
Type
Scientific
Primary contact
Prof Catherine Geissler
ORCID ID
Contact details
Department of Nutrition and Dietetics
King's College London
Franklin-Wilkins Building
Waterloo Bridge Wing Room 3.17
150 Stamford Street
London
SE1 9NH
United Kingdom
+44 (0) 20 7848 4351
catherine.geissler@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
MTHH
Study hypothesis
We hypothesise that consumption of milk thistle extract with a meal containing non-haem iron leads to a reduction in serum iron increase following the meal, due to the formation of iron-silybin complexes that render iron unavailable for mucosal uptake, but the milk-thistle-related reduction in post-prandial serum iron increase is not equal to the tea-related reduction in post-prandial serum iron increase.
Ethics approval
Approved by King's College Hospital REC on 21st April 2006 (reference number 06/Q0703/56).
Study design
Open-intervention pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Hereditary Haemochromatosis (HH)
Intervention
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 with test meal. The control will be the test meal with water.
All patients will ingest the treatment (Milk Thistle capsule) with a meal, the comparator (tea) with an identical meal and control (the meal alone) on three separate occasions, four to seven days apart, and in a random order. The meal will contain 15.2 mg non-radioactive non-haem iron and will consist of vegetarian shepherd's pie, fruit salad and juice. On each occasion, blood will be drawn once before and once hourly for four hours after the meal, for measurement of total serum iron.
Intervention type
Drug
Phase
Not Specified
Drug names
Legalon 140 mg (milk thistle extract)
Primary outcome measure
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 outcome measures
Not provided at time of registration
Overall trial start date
16/08/2006
Overall trial end date
16/10/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
10
Participant 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
Recruitment start date
16/08/2006
Recruitment end date
16/10/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Nutrition and Dietetics
London
SE1 9NH
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Hodgkin Building
Guy's Campus
London
SE1 1UL
United Kingdom
+44 (0) 20 7848 6981
robert.lechler@kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
This project is funded by the Haemochromatosis Society (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20628405
Publication citations
-
Results
Hutchinson C, Bomford A, Geissler CA, The iron-chelating potential of silybin in patients with hereditary haemochromatosis., Eur J Clin Nutr, 2010, 64, 10, 1239-1241, doi: 10.1038/ejcn.2010.136.