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| ID | Type | Description | Link |
|---|---|---|---|
| IZSTZ0_208432/1 | Other Grant/Funding Number | Swiss National Science Foundation |
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| Name | Class |
|---|---|
| Wageningen University and Research | OTHER |
| Sight and Life Foundation | UNKNOWN |
| Kamuzu University of Health Sciences | OTHER |
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Iron supplementation is the first line of treatment of iron deficiency in most women, but we do not know when the best time is to supplement in the context of the menstrual cycle. With this study, we aim to measure and compare iron status, hepcidin, inflammatory markers, hormones estrogen and progesterone and changes in iron absorption at various points throughout the menstrual cycle, with a long-term view to determine best time for iron supplementation in relation to the menstrual cycle.
To date, very few studies have assessed iron absorption in relation to a woman's menstrual cycle. Although oral iron supplementation is considered the first line of treatment for iron deficiency in most women, there is no knowledge on the relationship between this intervention in the context of the menstrual cycle, and more specifically there is no knowledge on its potential implications for the most appropriate timing of iron supplementation. A better understanding of iron absorption during the menstrual cycle as well as kinetics of key parameters could allow the design of adapted and/or new interventions (e.g., timing of iron supplementation in relation to different phases of the menstrual cycle) to mitigate iron deficiency in menstruating women and can inform programs aimed at addressing iron deficiency
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 54Fe | Experimental | Participants will receive 54Fe at two time points throughout their menstrual cycle. |
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| Experimental 57Fe | Experimental | Participants will receive 57Fe at two time points throughout their menstrual cycle. |
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| Experimental 58Fe | Experimental | Participants will receive 58Fe at two time points throughout their menstrual cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test meal labelled with 54Fe | Other | Each participant will receive 2 test meals containing 4mg each of isotopic tracer 54Fe |
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| Measure | Description | Time Frame |
|---|---|---|
| Fractional iron absorption (%) | Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the labelled test meals. | Day 2, 18, 22, 26 and 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin concentration (g/L) | Haemoglobin will be measured to determine presence of anaemia | Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28 and 40 |
| Serum ferritin (microg/L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ETH Zurich | Zurich | 8092 | Switzerland |
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| Test meal labelled with 57Fe | Other | Each participant will receive 2 test meals containing 4mg each of isotopic tracer 57Fe |
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| Test meal labelled with 58Fe | Other | Each participant will receive 2 test meals containing 4mg each of isotopic tracer 58Fe |
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Iron status parameter
| Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28 |
| Serum transferrin receptor (mg/L) | Iron status parameter | Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28 |
| Serum iron (microg/mL) | Iron status parameter | Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28 |
| Serum hepcidin (nmol/L) | Hepcidin, a major regulator of iron absorption and influenced by inflammation, will be measured | Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28 |
| Alpha-1-acid glycoprotein (g/L) | Chronic inflammation parameter | Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28 |
| C-reactive protein (mg/L) | Acute inflammation parameter | Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28 |
| Serum estradiol (pg/mL) | Hormonal parameter | Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28 |
| Serum progesterone (ng/mL) | Hormonal parameter | Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28 |
| Total iron binding capacity (microg/mL) | Total iron binding capacity will be measured to determine the presence of iron deficiency | Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28 |
| Menstrual blood volume loss/cycle | Semi-quantitative assessment to measure menstrual blood loss per cycle | Menstruation |
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| 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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