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临床试验/NCT03156712
NCT03156712已完成不适用

Serum Iron Increase With From Iron-enriched Aspergillus Compared to Ferrous Sulfate in Healthy Female Subjects

Iowa State University2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2013年5月29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
17
试验地点
2
主要终点
Serum iron

研究概览

简要总结

Ferrous sulfate is rapidly absorbed and the bolus of iron enters blood rather quickly possibly leading to higher concentrations of non-transferrin bound iron which induces oxidative stress. The objective of this study was to determine how quickly iron enters into blood stream from the iron-enriched Asperigillus oryzae (AspironTM, ASP) in contrast to ferrous sulfate. Seventeen healthy, female subjects (18-35 y) were randomized, double blind, cross-over experimental design with three treatments: 10 mg iron as FeSO4 and ASP as well as 20 mg iron as ASP.

详细描述

In a double-blinded cross-over design, 17 research participants were randomly given one of three iron-treatments : ferrous sulfate (10mg), AspironTM (10mg), and AspironTM (20mg). Each iron treatment was given with a test meal consisting of cabbage, green peas, green beans, soy sauce, peanut oil, 40 g baby carrots, steamed rice, and orange juice. Each subject consumed a meal with one of the three iron supplements in a random order and all participants consumed the three supplements 2 weeks in between each treatment. Prior to consuming the test meal with iron supplement for each treatment, blood was collected for baseline serum iron measuremt. Following consumption of the meal with iron, subsequent blood draws were taken every 30 minutes over the time period of 4 hours to assess the incease in serum iron. Ferritin, hepcidin, iron , and c-reactive protein concentrations were measured in the serum at baselime. After two weeks other treatments were administered to each participant. The serum iron response curves for each treatment were constructed and the area under the curve (AUC) was calculated with the change of serum iron from baseline.

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
Double (Participant, Investigator)

盲法说明

Both investigators and participants were blinded to the iron treatment in this double-blinded, crossover study. Three different iron supplements were given, whereby participants were either administered 10 mg FeSO4, 10 mg ASP Fe, or 20 mg ASP Fe.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Non-pregnant
  • Non-lactating
  • Non-smoker
  • Not taking medications
  • Not taking dietary supplements (vitamins or minerals)
  • No history of gastrointestinal conditions

排除标准

  • Any history of gastrointestinal conditions
  • On medications that interfere with iron absorption
  • Unwilling to stop taking dietary supplements (vitamins or minerals)
  • Lactating

结局指标

主要结局

Serum iron

时间窗: 12 hours

Area under the curve

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

Dr. Manju B. Reddy

Professor

Iowa State University

研究点 (2)

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