The effect of Milk Thistle extract versus tea on serum iron increase after a meal containing non-haem iron in Hereditary Haemochromatosis: a pilot study

ISRCTN ISRCTN10982081
DOI https://doi.org/10.1186/ISRCTN10982081
Secondary identifying numbers N/A
Submission date
28/07/2006
Registration date
12/09/2006
Last edited
25/02/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Catherine Geissler
Scientific

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

Phone +44 (0) 20 7848 4351
Email catherine.geissler@kcl.ac.uk

Study information

Study designOpen-intervention pilot study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymMTHH
Study objectivesWe 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(s)Approved by King's College Hospital REC on 21st April 2006 (reference number 06/Q0703/56).
Health condition(s) or problem(s) studiedHereditary Haemochromatosis (HH)
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Legalon 140 mg (milk thistle extract)
Primary outcome measureSerum 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 measuresNot provided at time of registration
Overall study start date16/08/2006
Completion date16/10/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants10
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment16/08/2006
Date of final enrolment16/10/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Nutrition and Dietetics
London
SE1 9NH
United Kingdom

Sponsor information

King's College London (UK)
University/education

Hodgkin Building
Guy's Campus
London
SE1 1UL
England
United Kingdom

Phone +44 (0) 20 7848 6981
Email robert.lechler@kcl.ac.uk
Website http://www.kcl.ac.uk
ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

Charity

This project is funded by the Haemochromatosis Society (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2010 Yes No