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Each year, 5 million packs of iron tablets are dispensed in England and Wales to treat anaemia due to iron deficiency. Iron tablets are not always easy to take. The investigators think that there could be ways to reduce the number of iron tablets needed, by increasing the dietary intake of iron. In this study the investigators will assess the efficacy and safety of a dietary iron supplement compared to iron tablets using controls and new biomarkers.
18 healthy individuals will be randomised to one of three arms, and for two consecutive mornings, will receive either an iron tablet (ferrous sulphate 200mg), a dietary iron supplement, or no agent.
Blood and urine samples will be collected pre-dose, and at stated intervals 2.5, 4, 7, 24 and 48 hours post first dose.
The standard deviations of data obtained in this pilot study will be used to perform power calculations for our future studies in this field.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Following randomisation,to no active intervention, blood and urine samples will be collected at 6 stated intervals over a 48 hour period Total number of participants in arm = 6 | |
| Iron control | Active Comparator | Following randomisation, on each of two consecutive mornings, the participant will receive a single dose of ferrous sulphate 200mg. Blood and urine samples will be collected pre first dose, and at 5 further stated intervals over a 48 hour period. Total number of participants in arm = 6 |
|
| Dietary supplement | Experimental | Following randomisation, on each of two consecutive mornings, the participant will receive the experimental dietary iron supplement. Blood and urine samples will be collected pre first dose, and at 5 further stated intervals over a 48 hour period. Toal participants in arm = 6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary supplement of iron | Dietary Supplement | 1 tablespoon of a dietary iron supplement containing 2.64mg of elemental iron |
|
| Measure | Description | Time Frame |
|---|---|---|
| Iron levels in blood tests | 48 hours |
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Inclusion Criteria:
To be a healthy, consenting volunteer not currently receiving iron supplements.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claire L Shovlin, PhD MA MB BChir FRCP | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellcome Trust-McMichael Clinical Research Facility, Imperial college London | London | W12 0NN | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Further analyses are in progress for full manuscript. | ||
| Result | Gilson C, Busbridge M, Shovlin CL, Iron tablet profiling. Hematology Reports 2013: 5 (s1),30-1 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 25, 2023 | |
| Reset | Mar 27, 2024 | |
| Release | Apr 3, 2024 | |
| Reset | Aug 21, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 25, 2023 | Mar 27, 2024 | |||
| Apr 3, 2024 |
| ID | Term |
|---|---|
| C020748 | ferrous sulfate |
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| Ferrous sulphate | Drug | 200mg coated dried tablet containing 65mg elemental iron, equivalent to prophylactic daily dose as defined by the British National Formulary |
|
| Aug 21, 2024 |