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临床试验/NCT02916654
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

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

申办方类型
Other
责任方
Sponsor

研究点 (1)

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