NCT02916654Unknown不适用
Sucrosomial Iron Supplementation in Anaemic Patients With Celiac Disease Not Tolerating Oral Ferrous Sulfate
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Hemoglobin
研究概览
简要总结
Sucrosomial iron (Sideral® Forte) is a preparation of ferric pyrophosphate conveyed within a phospholipid membrane associated with ascorbic acid, is a new-generation oral iron which shows a high gastrointestinal absorption and high bioavailability with a low incidence of side effects due to lack of any direct contact with intestinal mucosa. In comparison with the other standard oral iron preparations, sucrosomial iron seems to be a promising new strategy of iron replacement in CD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •proven celiac disease
- •iron deficiency anemia
排除标准
- •other autoimmne diseases
- •pregnancy psychiatric disorders
研究组 & 干预措施
sulphate iron
Active Comparator
patients administered with sulphate iron
干预措施: Sulphate iron (Drug)
sucrosomial iron
Experimental
patients administered with sucrosomial iron
干预措施: sucrosomial iron (Dietary Supplement)
结局指标
主要结局
Hemoglobin
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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