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Completed

NCT Number: NCT07563686

Measuring Iron Bioavailability From Oral Iron Supplements in Healthy Pre-menopausal Women Using Stable Isotopes

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.

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Key information

Age range

19 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

King's College London

London, Greater London, SE1 9NH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Allergy to iron supplements
  • BMI above 25
  • Pregnant
  • 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)

Treatment and study plan

5mg Spatone

Dietary Supplement

5mg Spatone

10mg Spatone

Dietary Supplement

10mg Spatone

15mg Spatone

Dietary Supplement

15mg Spatone

5mg ferrous sulphate

Dietary Supplement

5mg ferrous sulphate

10mg ferrous sulphate

Dietary Supplement

10 mg ferrous sulphate

15mg ferrous sulphate

Dietary Supplement

15mg ferrous sulphate

Primary outcomes

  1. Iron Status Indicators

    Time frame: 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.

Secondary outcomes

  1. Serum hepcidin levels

    Time frame: Baseline (Day 1) before 15mg supplementation and Day 2 ( 24 hours after 15mg supplementation)

    An additional blood sample will be collected the day after the administration of the 15 mg iron dose to assess the serum hepcidin response to high-dose iron from both ferrous sulphate and Spatone™.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study title

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

Acronym: BOIs

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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