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

NCT07563686 | Completed

• 1 other identifier: HR/DP-23/24-40266
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Iron Deficiency Anaemia Due to Dietary Causes

Keywords

iron deficiency anaemia

Outcome Measures

Primary Outcomes (1)

• Iron Status Indicators

  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.

  Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84

Secondary Outcomes (1)

• Serum hepcidin levels

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

Study Arms (6)

SP5

EXPERIMENTAL

Spatone 5mg

Dietary Supplement: 5mg Spatone

10mg Spatone

EXPERIMENTAL

10mg spatone

Dietary Supplement: 10mg Spatone

15mg Spatone

EXPERIMENTAL

15mg Spatone

Dietary Supplement: 15mg Spatone

5mg Ferrous sulphate

EXPERIMENTAL

5mg ferrous sulphate

Dietary Supplement: 5mg ferrous sulphate

10mg Ferrous sulphate

EXPERIMENTAL

10 mg ferrous sulphate

Dietary Supplement: 10mg ferrous sulphate

15mg Ferrous sulphate

EXPERIMENTAL

15mg ferrous sulphate

Dietary Supplement: 15mg ferrous sulphate

Interventions

5mg Spatone DIETARY_SUPPLEMENT

5mg Spatone

SP5

10mg Spatone DIETARY_SUPPLEMENT

10mg Spatone

10mg Spatone

15mg Spatone DIETARY_SUPPLEMENT

15mg Spatone

15mg Spatone

5mg ferrous sulphate DIETARY_SUPPLEMENT

5mg ferrous sulphate

5mg Ferrous sulphate

10mg ferrous sulphate DIETARY_SUPPLEMENT

10 mg ferrous sulphate

10mg Ferrous sulphate

15mg ferrous sulphate DIETARY_SUPPLEMENT

15mg ferrous sulphate

15mg Ferrous sulphate

Eligibility Criteria

• Age: 19 Years - 49 Years
• Gender Eligibility Details: Biological females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

King's College London

London, Greater London, SE1 9NH, United Kingdom

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a Randomised controlled cross over study measuring iron bioavailability from oral iron supplement. 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). Each volunteer will undergo six interventions, with a two-week interval between them. On the day of each intervention, a blood sample will be taken to measure either baseline levels of iron in haemoglobin or iron absorbed and incorporated into haemoglobin from the previous intervention administered two weeks prior.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: May 4, 2026
• Study Start: January 13, 2024
• Primary Completion: March 31, 2025
• Study Completion: January 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2025-02

Locations

GB (1)