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临床试验/EUCTR2006-002099-16-GB
EUCTR2006-002099-16-GB进行中(未招募)1 期

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

King's College London0 个研究点目标入组 0 人开始时间: 2006年7月23日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • (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

排除标准

  • (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.

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