Iron Deficiency and Hereditary Haemorrhagic Telangiectasia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Blood iron indices
研究概览
简要总结
Managing iron deficiency is important for more than 1 billion individuals worldwide, to avoid blood transfusions, or excessive strain on vital organs that depend on iron-containing haemoglobin to deliver oxygen to the tissues. Iron deficiency is a particular problem for people with the inherited condition hereditary haemorrhagic telangiectasia (HHT). Their iron deficiency and anaemia results from blood losses, especially from the nose (nosebleeds, and they often need additional iron to replace that lost through bleeding.
Our goal is to stratify HHT patients into high/low absorbers of iron; to define what extra iron they need to adjust for their current and likely future blood losses; and to work out how to achieve this most safely for each individual to improve their later health.
We will test the hypothesis that informed assessment of iron intake and post absorption cellular profiles changes the recommendations for iron intake for HHT patients.
详细描述
Relevant patients due to come to clinic or the programmed investigation unit will be offered the opportunity to participate in the study.
Up to 100 consenting individuals will
- have an additional 15 mls of supplementary research bloods taken
- receive a single tablet of ferrous sulphate 200mg
- fill in questionnaires that formally evaluate their nosebleed losses and dietary iron intake in the preceding 12 months
- have a second blood sample later that day (20 mls of blood)
The primary outcome measure is the change in serum iron levels post iron tablet.
Other outcome measures will include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hereditary haemorrhagic telangiectasia (HHT). Definite diagnosis of HHT by international criteria.
- •No iron tablets or treatment taken on day of assessment
- •Ability to provide informed consent.
排除标准
- •Inability to provide informed consent
- •Intercurrent infection or illness predicted to modify iron absorption.
- •Needle phobia.
研究组 & 干预措施
Iron treatment
INTERVENTION: Ferrous sulphate 200mg oral tablet
This is a single arm study. Individuals in this arm will
- have an additional 15 mls of supplementary research bloods taken with their usual clinic bloods
- receive a single tablet of ferrous sulphate 200mg
- fill in questionnaires that formally evaluate their nosebleed losses and dietary iron intake in the preceding 12 months
- have a second blood sample later that day (20 mls of blood
Total number of participants in arm = 100
干预措施: Ferrous sulphate 200mg oral tablet (Drug)
结局指标
主要结局
Blood iron indices
时间窗: 4-5 hours after iron tablet ingestion
次要结局
未报告次要终点