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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP5 | Experimental | Spatone 5mg |
|
| 10mg Spatone | Experimental | 10mg spatone |
|
| 15mg Spatone | Experimental | 15mg Spatone |
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| 5mg Ferrous sulphate | Experimental | 5mg ferrous sulphate |
|
| 10mg Ferrous sulphate | Experimental | 10 mg ferrous sulphate |
|
| 15mg Ferrous sulphate | Experimental | 15mg ferrous sulphate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5mg Spatone | Dietary Supplement | 5mg Spatone |
| |
| 10mg Spatone |
| 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 |
| 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 Spatoneā¢. | Baseline (Day 1) before 15mg supplementation and Day 2 ( 24 hours after 15mg supplementation) |
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Inclusion Criteria:
Exclusion Criteria:
Biological females
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College London | London | Greater London | SE1 9NH | United Kingdom |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 23, 2024 | Feb 5, 2026 |
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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.
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| 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 |
|
| Prot_000.pdf |
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C020748 | ferrous sulfate |
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