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

King's College London14 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Iron Deficiency Anaemia Due to Dietary Causes

Interventions

5mg SpatoneDIETARY_SUPPLEMENT

5mg Spatone

10mg SpatoneDIETARY_SUPPLEMENT

10mg Spatone

15mg SpatoneDIETARY_SUPPLEMENT

15mg Spatone

5mg ferrous sulphate

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

King's College London

London, Greater London, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84

Secondary Outcomes

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™.

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

Data from ClinicalTrials.gov

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