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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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13 July 2020 |
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Main ID: |
EUCTR2006-002099-16-GB |
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Date of registration:
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23/07/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The effect of milk thistle extract (Legalon) versus tea on serum iron increase after a meal containing non-haem iron in hereditary haemochromatosis - Dietary management of hereditary haemochromatosis: A pilot study
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Scientific title:
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The effect of milk thistle extract (Legalon) versus tea on serum iron increase after a meal containing non-haem iron in hereditary haemochromatosis - Dietary management of hereditary haemochromatosis: A pilot study |
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Date of first enrolment:
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13/07/2006 |
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Target sample size:
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10 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002099-16 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Black tea infusion
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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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) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
(i) Patients with allergy to any foods or medicines will be excluded from participating for their own safety.
(ii) 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.
(iii) Patients with diabetes will be excluded from taking part in the study because of the requirement to fast prior to ingestion of the test meals.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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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
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Intervention(s)
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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
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Primary Outcome(s)
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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.
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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.
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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.
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Secondary ID(s)
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06/Q0703/56
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 19/04/2006
Contact:
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