Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/07/2006
Date assigned
12/09/2006
Last edited
25/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.kcl.ac.uk

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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20628405

Publication citations

  1. 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.

Additional files

Editorial Notes