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

Randomised Cross Over Study 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.

Study Overview

• Status: Completed
• Conditions: Iron Deficiency Anaemia Due to Dietary Causes
• Intervention / Treatment: Dietary supplement: 5mg Spatone; Dietary supplement: 10mg Spatone; Dietary supplement: 15mg Spatone; Dietary supplement: 5mg ferrous sulphate; Dietary supplement: 10mg ferrous sulphate; Dietary supplement: 15mg ferrous sulphate

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Greater London
    • London, Greater London, United Kingdom, SE1 9NH
      • King's College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SP5; Spatone 5mg	Dietary supplement: 5mg Spatone; 5mg Spatone
Experimental: 10mg Spatone; 10mg spatone	Dietary supplement: 10mg Spatone; 10mg Spatone
Experimental: 15mg Spatone	Dietary supplement: 15mg Spatone; 15mg Spatone
Experimental: 5mg Ferrous sulphate; 5mg ferrous sulphate	Dietary supplement: 5mg ferrous sulphate; 5mg ferrous sulphate
Experimental: 10mg Ferrous sulphate; 10 mg ferrous sulphate	Dietary supplement: 10mg ferrous sulphate; 10 mg ferrous sulphate
Experimental: 15mg Ferrous sulphate; 15mg ferrous sulphate	Dietary supplement: 15mg ferrous sulphate; 15mg ferrous sulphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum hepcidin levels	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™.	Baseline (Day 1) before 15mg supplementation and Day 2 ( 24 hours after 15mg supplementation)

Collaborators and Investigators

• Sponsor: King's College London

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2024
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): January 31, 2026

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: iron deficiency anaemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia; Iron Metabolism Disorders; Anemia, Hypochromic; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Anemia, Iron-Deficiency; ferrous sulfate
• Other Study ID Numbers: HR/DP-23/24-40266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No