Iron Deficiency Anaemia Due to Dietary Causes
Conditions
Keywords
iron deficiency anaemia
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.
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.
Interventions
DIETARY_SUPPLEMENT5mg Spatone
5mg Spatone
DIETARY_SUPPLEMENT10mg Spatone
10mg Spatone
DIETARY_SUPPLEMENT15mg Spatone
15mg Spatone
DIETARY_SUPPLEMENT5mg ferrous sulphate
5mg ferrous sulphate
DIETARY_SUPPLEMENT10mg ferrous sulphate
10 mg ferrous sulphate
DIETARY_SUPPLEMENT15mg ferrous sulphate
15mg ferrous sulphate
Sponsors
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 49 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Iron Status Indicators | 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
| Measure | Time frame | Description |
|---|---|---|
| Serum hepcidin levels | 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™. |
Countries
United Kingdom
Outcome results
None listed