此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Iron Absorption From a Nutritional Iron Supplement

2026年11月2日 更新者:Nicole Stoffel、ETH Zurich

Conventional oral iron supplements often cause gastrointestinal side effects and are limited by poor bioavailability, leaving unabsorbed iron to reach the colon. Hydrocolloid-based hydrogel matrix formulations designed for gradual iron release present a promising approach to improve iron absorption. This study evaluates fractional iron absorption (FIA) from three low-dose hydrogel formulations containing ferrous fumarate compared with ferrous fumarate without a hydrogel matrix. Test products will be administered with water, with and without a standardized breakfast. All formulations will be intrinsically labelled with stable iron isotopes ( 57Fe or 54Fe), and FIA will be determined 14 days after administration based on erythrocyte iron incorporation. In this randomized, within-subject corssover study conducted in non-anemic, iron-depleted women, each participant will receive all test conditions and serve as her own control.

研究概览

研究类型

介入性

注册 (估计的)

22

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Canton of Zurich
      • Zurich、Canton of Zurich、瑞士、8006

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 45年 (成人)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Female aged 18 to 45 years
  • Plasma ferritin <30 µg/L
  • Body mass index (BMI) 18.5 kg/m2 - 24.9 kg/m2.
  • Body weight <65 kg.
  • Signed informed consent
  • Sufficient command of English (mother tongue or B2 level)

Exclusion Criteria:

  • Anemia, defined as hemoglobin (Hb) <120 g/L (<12.0 g/dL).
  • Elevated systemic inflammatory markers (C-reactive protein >5.0 mg/L).
  • Chronic digestive, renal and/or metabolic diseases
  • Chronic medications (except for contraceptives)
  • Use of vitamin, mineral, or pre-/Pprobiotic supplements in the 2 weeks before or during the study
  • Blood transfusion, blood donation or significant blood loss (>400ml) over the past 4 months
  • Difficulty with blood withdrawal
  • Pregnancy (tested in serum/urine) or intention to become pregnant during the course of the study
  • Lactation
  • Previous participation in a study using stable isotopes or participation in any clinical study within the last 30 days
  • Participants who cannot be expected to comply with the study protocol (e.g. not available on certain study appointments)
  • Inability to understand the information sheet and the informed consent form due to cognitive or language reasons
  • Smoking (>1 cigarette/week)
  • Vegan diet (the standardized breakfast contains plain whole milk yogurt and butter)

Special exclusion criteria for participants in the MRI imaging sub-study (n=9):

  • Presence of a heart pacemaker, neurostimulator, or any other active implanted electronic device.
  • Use of a hearing aid that cannot be safely removed for the MRI examination.
  • Use of removable dentures that cannot be safely removed for the MRI examination.
  • History of surgery on the head or heart involving implanted material that is not confirmed MRI-safe.
  • Presence of metallic objects in the body (e.g. implants, magnets, metal splinters, gunshot fragments, tattoos, piercings, or surgical clips) that are not confirmed MRI-safe.
  • History of metal splinter injury (e.g. ocular foreign body) or occupational exposure associated with increased risk of retained metal fragments.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:FeHydro-A with breakfast (Condition 1)

FeHydro-A with sodium ascorbate, consumed with a standardized breakfast

FeHydro-A (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + Standardized Breakfast

其他名称:
  • FeHydroA
实验性的:FeHydro-B with breakfast (Condition 2)

FeHydro-B without sodium ascorbate, consumed with a standardized breakfast

FeHydro-B (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + Standardized Breakfast

其他名称:
  • FeHydro B
实验性的:FeHydro-A without breakfast (Condition 3)

FeHydro-A with sodium ascorbate, consumed without breakfast

FeHydro-A (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + 300 mL Water

实验性的:FeHydro-B without breakfast (Condition 4)

FeHydro-B without sodium ascorbate, consumed without breakfast

FeHydro-B (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + 300 mL Water

实验性的:FeHydro-C with breakfast (Condition 5)

FeHydro-C with sodium ascorbate and gum arabic, consumed with a standardized breakfast

FeHydro-C (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + Standardized Breakfast

有源比较器:Control with breakfast (Condition 6)

Control ferrous fumarate, consumed with a standardized breakfast

Control (20 mg elemental iron as ferrous fumarate without hydrogel matrix, in gelatin capsule; labeled with 57Fe or 54Fe) + Standardized Breakfast

有源比较器:Control without breakfast (Condition 7)

Control ferrous fumarate, consumed without breakfast

Control (20 mg elemental iron as ferrous fumarate without hydrogel matrix, in gelatin capsule; labeled with 57Fe or 54Fe) + 300 mL Water

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Fractional Iron Absorption
大体时间:14 days after administration of each labelled test condition

Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in red blood cells

14 days after administration of each labelled test condition

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2027年2月1日

研究注册日期

首次提交

2026年11月2日

首先提交符合 QC 标准的

2026年11月2日

首次发布 (实际的)

2026年11月6日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data (IPD) will not be made publicly available to protect participant privacy and maintain confidentiality regarding proprietary formulation data. De-identified, aggregated study results and primary outcome data will be published in peer-reviewed scientific journals and made available via public study registries upon completion of the trial.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅