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| Name | Class |
|---|---|
| Mahidol University | OTHER |
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Iron deficiency anemia (IDA) is common during pregnancy and has adverse effects on the mother, fetus and newborn. Oral iron supplements are usually recommended to prevent ID/IDA during pregnancy.
The aim of this study is to define an iron supplementation schedule with maximal absorption using serum hepcidin profiles and stable iron isotopes in pregnant women. In this randomized, open-label trial, fractional and total iron absorption will be compared from daily dosing with 60 mg iron versus alternate day and every third day dosing with 120 mg iron in pregnant Thai women with low iron stores (n=28) during their second trimester of pregnancy.
This study could have wide impact, providing the evidence base for revised, improved recommendations for iron supplementation during pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral iron supplementation | Experimental | Participants go through 3 cycles of oral iron Supplementation (60mg daily vs alternate day dosing, 120mg daily vs alternate day dosing, 120mg daily vs every third-day dosing) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Labeled iron solution (60mg and 120mg Ferrous Fumarate) | Dietary Supplement | 3 doses of 60mg iron as ferrous fumarate are given on one consecutive day and one alternate day (e.g., days 1, 2, 4); 3 doses of 120mg iron as ferrous fumarate are given on one consecutive and one alternate day (e.g., days 20, 21, 23); 3 doses of 120mg iron as ferrous fumarate are given on one consecutive and one 3rd day (e.g., days 37, 38, 41). Iron doses are labeled with 4mg of a stable isotope in 200ml deionized water (57Fe, 58Fe or 54Fe). Participants will be randomly assigned to start with 60mg iron daily vs alternate day dosing, 120mg daily vs alternate day dosing or 120mg daily vs every-third day dosing. |
| Measure | Description | Time Frame |
|---|---|---|
| Fractional iron absorption in % | Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the 60mg daily vs alternate day cycle | Day 18 |
| Fractional iron absorption in % | Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the 120mg daily vs alternate day cycle | Day 35 |
| Fractional iron absorption in % | Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the 120mg daily vs every third day cycle | Day 53 |
| Total iron absorption in % | Fractional iron absorption measured from the 60mg daily vs alternate day cycle multiplied by the dose | Day 18 |
| Total iron absorption in % | Fractional iron absorption measured from the 120mg daily vs alternate day cycle multiplied by the dose | Day 35 |
| Total iron absorption in % | Fractional iron absorption measured from the 120mg daily vs every third day cycle multiplied by the dose | Day 53 |
| Serum Hepcidin | in the morning before first supplement intake of the 60mg daily vs alternate day cycle | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Ferritin (SF) | in the morning before first supplement intake | Screening |
| Serum Ferritin (SF) | in the morning before first supplement intake of the 60mg daily vs alternate day cycle |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mahidol University | Salaya | Changwat Nakhon Pathom | 73170 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37357807 | Derived | von Siebenthal HK, Moretti D, Zimmermann MB, Stoffel NU. Effect of dietary factors and time of day on iron absorption from oral iron supplements in iron deficient women. Am J Hematol. 2023 Sep;98(9):1356-1363. doi: 10.1002/ajh.26987. Epub 2023 Jun 26. |
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| ID | Term |
|---|---|
| C031621 | ferrous fumarate |
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each subject acts as her own control by going through all the three supplementation cycles. Women will be randomly assigned to start with the 60mg daily vs alternate day, 120mg daily vs alternate day or 120mg daily vs every third day supplementation cycle.
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|
| Serum Hepcidin |
in the morning before second supplement intake of the 60mg daily vs alternate day cycle |
| Day 2 |
| Serum Hepcidin | in the morning before third supplement intake of the 60mg daily vs alternate day cycle | Day 4 |
| Serum Hepcidin | in the morning before first supplement intake of 120mg daily vs alternate day cycle | Day 18 |
| Serum Hepcidin | in the morning before second supplement intake of 120mg daily vs alternate day cycle | Day 19 |
| Serum Hepcidin | in the morning before third supplement intake of 120mg daily vs alternate day cycle | Day 21 |
| Serum Hepcidin | in the morning before first supplement intake of the 120mg daily vs every third day cycle | Day 35 |
| Serum Hepcidin | in the morning before second supplement intake of the 120mg daily vs every third day cycle | Day 36 |
| Serum Hepcidin | in the morning before third supplement intake of the 120mg daily vs every third day cycle | Day 39 |
| Serum Hepcidin | in the morning 14 days after last supplement intake the 120mg daily vs every third day cycle | Day 53 |
| Day 1 |
| Serum Ferritin (SF) | in the morning before first supplement intake of the 120mg daily vs alternate day cycle | Day 18 |
| Serum Ferritin (SF) | in the morning before first supplement intake of the 120mg daily vs every third day cycle | Day 35 |
| Serum Ferritin (SF) | in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle | Day 53 |
| Hemoglobin (Hb) | in the morning before first supplement intake | Screening |
| Hemoglobin (Hb) | in the morning before first supplement intake of the 60mg daily vs alternate day cycle | Day 1 |
| Hemoglobin (Hb) | in the morning before first supplement intake of the 120mg daily vs alternate day cycle | Day 18 |
| Hemoglobin (Hb) | in the morning before first supplement intake of the 120mg daily vs every third day cycle | Day 35 |
| Hemoglobin (Hb) | in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle | Day 53 |
| Soluble transferrin receptor (sTfR) | in the morning before first supplement intake of the 60mg daily vs alternate day cycle | Day 1 |
| Soluble transferrin receptor (sTfR) | in the morning before first supplement intake of the 120mg daily vs alternate day cycle | Day 18 |
| Soluble transferrin receptor (sTfR) | in the morning before first supplement intake of the 120mg daily vs every third day cycle | Day 35 |
| Soluble transferrin receptor (sTfR) | in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle | Day 53 |
| C-reactive protein (CRP) | in the morning before first supplement intake of the 60mg daily vs alternate day cycle | Day 1 |
| C-reactive protein (CRP) | in the morning before first supplement intake of the 120mg daily vs alternate day cycle | Day 18 |
| C-reactive protein (CRP) | in the morning before first supplement intake of the 120mg daily vs every third day cycle | Day 35 |
| C-reactive protein (CRP) | in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle | Day 53 |
| Alpha-1-acid glycoprotein (AGP) | in the morning before first supplement intake of the 60mg daily vs alternate day cycle | Day 1 |
| Alpha-1-acid glycoprotein (AGP) | in the morning before first supplement intake of the 120mg daily vs alternate day cycle | Day 18 |
| Alpha-1-acid glycoprotein (AGP) | in the morning before first supplement intake of the 120mg daily vs every third day cycle | Day 35 |
| Alpha-1-acid glycoprotein (AGP) | in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle | Day 53 |
| Serum Hepcidin | in the afternoon after first supplement intake of the 60mg daily vs alternate day cycle | Day 1 |
| Serum Hepcidin | in the afternoon after first supplement intake of the 120mg daily vs alternate day cycle | Day 18 |
| Serum Hepcidin | in the afternoon 14 days after third supplement intake of the 120mg daily vs every third day cycle | Day 53 |
| Serum Iron (SFe) | in the morning before first supplement intake of the 60mg daily vs alternate day cycle | Day 1 |
| Serum Iron (SFe) | in the morning before second supplement intake of the 60mg daily vs alternate day cycle | Day 2 |
| Serum Iron (SFe) | in the morning before third supplement intake of the 60mg daily vs alternate day cycle | Day 4 |
| Serum Iron (SFe) | in the afternoon after first supplement intake of the 60mg daily vs alternate day cycle | Day 1 |
| Serum Iron (SFe) | in the morning before the first supplement intake of the 120mg daily vs alternate day cycle | Day 18 |
| Serum Iron (SFe) | in the morning before the second supplement intake of the 120mg daily vs alternate day cycle | Day 19 |
| Serum Iron (SFe) | in the morning before the third supplement intake of the 120mg daily vs alternate day cycle | Day 21 |
| Serum Iron (SFe) | in the afternoon after the first supplement intake of the 120mg daily vs alternate day cycle | Day 18 |
| Serum Iron (SFe) | in the morning before the first supplement intake of the 120mg daily vs every third day cycle | Day 35 |
| Serum Iron (SFe) | in the morning before the second supplement intake of the 120mg daily vs every third day cycle | Day 36 |
| Serum Iron (SFe) | in the morning before the third supplement intake of the 120mg daily vs every third day cycle | Day 39 |
| Serum Iron (SFe) | in the morning 14 days after the last supplement intake of the 120mg daily vs every third day cycle | Day 53 |
| Serum Iron (SFe) | in the afternoon 14 days after the last supplement intake of the 120mg daily vs every third day cycle | Day 53 |
| Total Iron Binding Capacity (TIBC) | in the morning before first supplement intake of the 60mg daily vs alternate day cycle | Day 1 |
| Total Iron Binding Capacity (TIBC) | in the morning before second supplement intake of the 60mg daily vs alternate day cycle | Day 2 |
| Total Iron Binding Capacity (TIBC) | in the morning before third supplement intake of the 60mg daily vs alternate day cycle | Day 4 |
| Total Iron Binding Capacity (TIBC) | in the afternoon after first supplement intake of the 60mg daily vs alternate day cycle | Day 1 |
| Total Iron Binding Capacity (TIBC) | in the morning before first supplement intake of the 120mg daily vs alternate day cycle | Day 18 |
| Total Iron Binding Capacity (TIBC) | in the morning before second supplement intake of the 120mg daily vs alternate day cycle | Day 19 |
| Total Iron Binding Capacity (TIBC) | in the morning before third supplement intake of the 120mg daily vs alternate day cycle | Day 21 |
| Total Iron Binding Capacity (TIBC) | in the afternoon after first supplement intake of the 120mg daily vs alternate day cycle | Day 18 |
| Total Iron Binding Capacity (TIBC) | in the morning before first supplement intake of the 120mg daily vs every third day cycle | Day 35 |
| Total Iron Binding Capacity (TIBC) | in the morning before second supplement intake of the 120mg daily vs every third day cycle | Day 36 |
| Total Iron Binding Capacity (TIBC) | in the morning before third supplement intake of the 120mg daily vs every third day cycle | Day 39 |
| Total Iron Binding Capacity (TIBC) | in the morning 14 after last supplement intake of the 120mg daily vs every third day cycle | Day 53 |
| Total Iron Binding Capacity (TIBC) | in the afternoon 14 after last supplement intake of the 120mg daily vs every third day cycle | Day 53 |