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Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem worldwide, especially in women of reproductive age and young children. Iron supplementation is an effective strategy to prevent and treat ID and IDA. There is a lack of data on iron bioavailability from different supplementation regimens and how to optimize bioavailability in a cost-effective and patient-friendly way. The daily supplementation with 1-4 mg Fe/kg body weight for 3 months is reported to be the most effective method to rapidly increase iron stores in subjects with ID and IDA. In IDA patients, medical practitioners often prescribe supplementation regimens with 120 mg iron per day split into 2 doses with 60 mg iron, arguing that the splitting would increase iron bioavailability compared with one single high dose. However, there is no scientific evidence for this assumption; to the contrary, results from a recent study suggest that iron bioavailability from a second supplementation dose of iron after a first supplementation dose of iron is impaired due to increased hepcidin levels. To address this bioavailability issue, the present study will determine iron absorption from 120 mg iron administered for 3 consecutive days and compare it with that from 2 doses of 60 mg iron per day administered for 3 consecutive days. The investigators hypothesize that the iron bioavailability from the single daily dose will be lower than that from the 2 doses. By measuring also hepcidin, this study will provide important insights on the iron bioavailability from a single dose of iron and on the same amount iron split into two doses (b.i.d. administration).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single oral iron supplement per day (120 mg) | Experimental | Single oral iron dose of 120 mg per day for 3 consecutive days |
|
| B.i.d. oral iron supplement (2x 60 mg) | Active Comparator | Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single oral iron dose of 120 mg per day for 3 consecutive days | Dietary Supplement |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Iron bio-availability (%) from oral iron supplementation (3x 120 mg) | Iron bioavailability will be assessed with stable isotopic labels. The shift in the isotopic ratio in human whole blood will be measured with Inductively coupled plasma mass spectrometry (ICP-MS). | 3 days |
| Serum hepcidin concentrations on the 1st day of iron supplementation | 1 day | |
| Iron bio-availability (%) from oral iron supplementation (6x 60 mg) | Iron bioavailability will be assessed with stable isotopic labels. The shift in the isotopic ratio in human whole blood will be measured with Inductively coupled plasma mass spectrometry (ICP-MS). | 6 days |
| Serum hepcidin concentrations on the 2nd day of iron supplementation | 2 days | |
| Serum hepcidin concentrations on the 3rd day of iron supplementation | 3 days | |
| Serum hepcidin concentrations on the 4th day of iron supplementation | 4 days | |
| Serum hepcidin concentrations on the 5th day of iron supplementation | 5 days | |
| Serum hepcidin concentrations on the 6th day of iron supplementation | 6 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Nutrition Laboratory | Zurich | Canton of Zurich | 8092 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29032957 | Derived | Stoffel NU, Cercamondi CI, Brittenham G, Zeder C, Geurts-Moespot AJ, Swinkels DW, Moretti D, Zimmermann MB. Iron absorption from oral iron supplements given on consecutive versus alternate days and as single morning doses versus twice-daily split dosing in iron-depleted women: two open-label, randomised controlled trials. Lancet Haematol. 2017 Nov;4(11):e524-e533. doi: 10.1016/S2352-3026(17)30182-5. Epub 2017 Oct 9. |
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| Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive days |
| Dietary Supplement |
|
| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| D000740 | Anemia |
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000747 | Anemia, Hypochromic |
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