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 |
| Protocol serial number | N/A |
| Sponsor | King's College London (UK) |
| Funder | This project is funded by the Haemochromatosis Society (UK) |
- 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
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 |
|---|---|
| catherine.geissler@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open-intervention pilot study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study acronym | MTHH |
| Study objectives | 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(s) | Approved by King's College Hospital REC on 21st April 2006 (reference number 06/Q0703/56). |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Legalon 140 mg (milk thistle extract) |
| Primary outcome measure(s) |
Serum iron increase after the test meal on each of three occasions (meal with milk thistle, versus meal with tea, versus meal with water). |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 16/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 10 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 16/08/2006 |
| Date of final enrolment | 16/10/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Nutrition and Dietetics
London
SE1 9NH
United Kingdom
SE1 9NH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
