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临床试验/NCT03660462
NCT03660462已完成不适用

Iron Bioavailability of High Surface Area Ferric Phosphate in Thai Women

Swiss Federal Institute of Technology2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2018年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
Fractional iron absorption

研究概览

简要总结

The primary objective of this study is to compare iron absorption of high surface area ferric phosphate with that of ferrous sulfate and bulk ferric phosphate in a rice-based meal in non-pregnant women.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women of reproductive age (18 to 49 years) in Thailand
  • BMI < 23 kg/m2
  • Body weight < 65 kg
  • Mildly anaemic to normocythemic (Hb 80-110 g/L)
  • Ferritin < 25 µg/L
  • Not pregnant (confirmed by pregnancy test stripe) or lactating
  • No inflammation (CRP < 5 mg/L)
  • Having provided written informed consent

排除标准

  • Haemoglobinopathies (except heterozygosity for haemoglobin E and alpha-thalassemia 1)
  • Coeliac disease or other chronic diseases of malabsorption that could influence iron absorption or metabolism
  • Blood donation or significant blood loss due to surgery or accident < 4 months before start of the study
  • Consumption of vitamin or mineral supplements 2 weeks before start of the study
  • Regular use of medication (except oral contraceptives), that influences iron absorption
  • Chronic inflammatory disease

结局指标

主要结局

Fractional iron absorption

时间窗: Measured 14 days after consumption of the 4 different types of iron vehicles (Days 16 and 31)

Iron absorption will be determined by measurement of the isotopic ratio change from the 4 different types of iron vehicles (FeSO4 fortified rice test meal, FePO4 fortified rice test meal, HiFePO4 1 fortified rice test meal, HiFePO4 2 fortified rice test meal).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Michael B. Zimmermann

Prof. Dr. med.

Swiss Federal Institute of Technology

研究点 (2)

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