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临床试验/NCT07563686
NCT07563686已完成不适用

Randomised Cross Over Study Measuring Iron Bioavailability From Oral Iron Supplements in Healthy Pre-menopausal Women Using Stable Isotopes

King's College London1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2024年1月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
Iron Status Indicators

研究概览

简要总结

In this study the investigators will compare iron absorption from 3 doses of iron (5, 10, 15 mg, given as either Spatone™ or ferrous sulphate). Our primary objective is to determine iron absorption from each preparation by measuring stable isotope (57Fe) incorporation into haemoglobin.

详细描述

The study is designed to comprehensively evaluate iron absorption by directly comparing the efficacy of Spatone™ with that of ferrous sulphate. It aims to gather dose-response information to understand how varying doses influence iron absorption. Additionally, the study seeks to investigate the impact of iron absorption on serum hepcidin levels, which is a significant factor as elevated hepcidin levels can inhibit both the absorption and utilization of iron. Understanding these dynamics is vital for improving treatments for conditions related to iron deficiency and for optimizing iron supplementation strategies. Three doses of iron either as Spatone™ or ferrous sulphate will be given to each participant. Our hypotheses are: 1. There will be a dose-dependent decrease in fractional iron absorption from both Spatone™ and ferrous sulphate preparations; 2. There will be no significant difference in iron absorption between Spatone™ and ferrous sulphate; 3. Spatone™ and ferrous sulphate will not affect hepcidin levels, even at the highest dose of each preparation used in this study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Healthy pre-menopausal women
  • Aged 19-49 years
  • With low iron stores (below 30 μg/L serum ferritin; normal range 30-100 μg/L).

排除标准

  • Allergy to iron supplements
  • BMI above 25
  • Post-menopausal women
  • History of alcohol or substance abuse
  • Reported history of CVD, diabetes, cancer, kidney, liver or intestinal disease, gastrointestinal disorder
  • Use of drugs likely to alter gastrointestinal function
  • Donated blood recently (within the last 3 months prior to screening visit)

研究组 & 干预措施

15mg Spatone

Experimental

15mg Spatone

干预措施: 15mg Spatone (Dietary Supplement)

SP5

Experimental

Spatone 5mg

干预措施: 5mg Spatone (Dietary Supplement)

10mg Spatone

Experimental

10mg spatone

干预措施: 10mg Spatone (Dietary Supplement)

5mg Ferrous sulphate

Experimental

5mg ferrous sulphate

干预措施: 5mg ferrous sulphate (Dietary Supplement)

10mg Ferrous sulphate

Experimental

10 mg ferrous sulphate

干预措施: 10mg ferrous sulphate (Dietary Supplement)

15mg Ferrous sulphate

Experimental

15mg ferrous sulphate

干预措施: 15mg ferrous sulphate (Dietary Supplement)

结局指标

主要结局

Iron Status Indicators

时间窗: Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84

The baseline blood sample, taken prior to the first intervention, will establish the participant's iron status before any treatment is administered. This includes, but is not limited to, serum ferritin, haemoglobin, and transferrin saturation. Post-Intervention Iron Status: Subsequent blood samples, taken two weeks after each intervention will be analysed to assess iron absorption from each supplemental iron preparation.

次要结局

  • Serum hepcidin levels(Baseline (Day 1) before 15mg supplementation and Day 2 ( 24 hours after 15mg supplementation))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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