Optimizing Oral Iron Supplementation Regimens During Pregnancy Using Serum Hepcidin Profiles and Iron Stable Isotopes: Defining a Dosing Regimen With Maximal Absorption and Minimal Gastrointestinal Side Effects
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All trials for Iron Deficiency Anemia of Pregnancy All trials of Labeled iron solution (60mg and 120mg Ferrous Fumarate)
-Summary
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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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| oral iron supplementation | Experimental | Dietary Supplement: Labeled iron solution (60mg and 120mg Ferrous Fumarate) | 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) |
- 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.
+Outcome measures
Primary outcomes
- Fractional iron absorption in % [Day 18]: Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the 60mg daily vs alternate day cycle
- Fractional iron absorption in % [Day 35]: Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the 120mg daily vs alternate day cycle
- Fractional iron absorption in % [Day 53]: Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the 120mg daily vs every third day cycle
- Total iron absorption in % [Day 18]: Fractional iron absorption measured from the 60mg daily vs alternate day cycle multiplied by the dose
- Total iron absorption in % [Day 35]: Fractional iron absorption measured from the 120mg daily vs alternate day cycle multiplied by the dose
- Total iron absorption in % [Day 53]: Fractional iron absorption measured from the 120mg daily vs every third day cycle multiplied by the dose
- Serum Hepcidin [Day 1]: in the morning before first supplement intake of the 60mg daily vs alternate day cycle
- Serum Hepcidin [Day 2]: in the morning before second supplement intake of the 60mg daily vs alternate day cycle
- Serum Hepcidin [Day 4]: in the morning before third supplement intake of the 60mg daily vs alternate day cycle
- Serum Hepcidin [Day 18]: in the morning before first supplement intake of 120mg daily vs alternate day cycle
- Serum Hepcidin [Day 19]: in the morning before second supplement intake of 120mg daily vs alternate day cycle
- Serum Hepcidin [Day 21]: in the morning before third supplement intake of 120mg daily vs alternate day cycle
- Serum Hepcidin [Day 35]: in the morning before first supplement intake of the 120mg daily vs every third day cycle
- Serum Hepcidin [Day 36]: in the morning before second supplement intake of the 120mg daily vs every third day cycle
- Serum Hepcidin [Day 39]: in the morning before third supplement intake of the 120mg daily vs every third day cycle
- Serum Hepcidin [Day 53]: in the morning 14 days after last supplement intake the 120mg daily vs every third day cycle
Secondary outcomes
- Serum Ferritin (SF) [Screening]: in the morning before first supplement intake
- Serum Ferritin (SF) [Day 1]: in the morning before first supplement intake of the 60mg daily vs alternate day cycle
- Serum Ferritin (SF) [Day 18]: in the morning before first supplement intake of the 120mg daily vs alternate day cycle
- Serum Ferritin (SF) [Day 35]: in the morning before first supplement intake of the 120mg daily vs every third day cycle
- Serum Ferritin (SF) [Day 53]: in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle
- Hemoglobin (Hb) [Screening]: in the morning before first supplement intake
- Hemoglobin (Hb) [Day 1]: in the morning before first supplement intake of the 60mg daily vs alternate day cycle
- Hemoglobin (Hb) [Day 18]: in the morning before first supplement intake of the 120mg daily vs alternate day cycle
- Hemoglobin (Hb) [Day 35]: in the morning before first supplement intake of the 120mg daily vs every third day cycle
- Hemoglobin (Hb) [Day 53]: in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle
- Soluble transferrin receptor (sTfR) [Day 1]: in the morning before first supplement intake of the 60mg daily vs alternate day cycle
- Soluble transferrin receptor (sTfR) [Day 18]: in the morning before first supplement intake of the 120mg daily vs alternate day cycle
- Soluble transferrin receptor (sTfR) [Day 35]: in the morning before first supplement intake of the 120mg daily vs every third day cycle
- Soluble transferrin receptor (sTfR) [Day 53]: in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle
- C-reactive protein (CRP) [Day 1]: in the morning before first supplement intake of the 60mg daily vs alternate day cycle
- C-reactive protein (CRP) [Day 18]: in the morning before first supplement intake of the 120mg daily vs alternate day cycle
- C-reactive protein (CRP) [Day 35]: in the morning before first supplement intake of the 120mg daily vs every third day cycle
- C-reactive protein (CRP) [Day 53]: in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle
- Alpha-1-acid glycoprotein (AGP) [Day 1]: in the morning before first supplement intake of the 60mg daily vs alternate day cycle
- Alpha-1-acid glycoprotein (AGP) [Day 18]: in the morning before first supplement intake of the 120mg daily vs alternate day cycle
- Alpha-1-acid glycoprotein (AGP) [Day 35]: in the morning before first supplement intake of the 120mg daily vs every third day cycle
- Alpha-1-acid glycoprotein (AGP) [Day 53]: in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle
- Serum Hepcidin [Day 1]: in the afternoon after first supplement intake of the 60mg daily vs alternate day cycle
- Serum Hepcidin [Day 18]: in the afternoon after first supplement intake of the 120mg daily vs alternate day cycle
- Serum Hepcidin [Day 53]: in the afternoon 14 days after third supplement intake of the 120mg daily vs every third day cycle
- Serum Iron (SFe) [Day 1]: in the morning before first supplement intake of the 60mg daily vs alternate day cycle
- Serum Iron (SFe) [Day 2]: in the morning before second supplement intake of the 60mg daily vs alternate day cycle
- Serum Iron (SFe) [Day 4]: in the morning before third supplement intake of the 60mg daily vs alternate day cycle
- Serum Iron (SFe) [Day 1]: in the afternoon after first supplement intake of the 60mg daily vs alternate day cycle
- Serum Iron (SFe) [Day 18]: in the morning before the first supplement intake of the 120mg daily vs alternate day cycle
- Serum Iron (SFe) [Day 19]: in the morning before the second supplement intake of the 120mg daily vs alternate day cycle
- Serum Iron (SFe) [Day 21]: in the morning before the third supplement intake of the 120mg daily vs alternate day cycle
- Serum Iron (SFe) [Day 18]: in the afternoon after the first supplement intake of the 120mg daily vs alternate day cycle
- Serum Iron (SFe) [Day 35]: in the morning before the first supplement intake of the 120mg daily vs every third day cycle
- Serum Iron (SFe) [Day 36]: in the morning before the second supplement intake of the 120mg daily vs every third day cycle
- Serum Iron (SFe) [Day 39]: in the morning before the third supplement intake of the 120mg daily vs every third day cycle
- Serum Iron (SFe) [Day 53]: in the morning 14 days after the last supplement intake of the 120mg daily vs every third day cycle
- Serum Iron (SFe) [Day 53]: in the afternoon 14 days after the last supplement intake of the 120mg daily vs every third day cycle
- Total Iron Binding Capacity (TIBC) [Day 1]: in the morning before first supplement intake of the 60mg daily vs alternate day cycle
- Total Iron Binding Capacity (TIBC) [Day 2]: in the morning before second supplement intake of the 60mg daily vs alternate day cycle
- Total Iron Binding Capacity (TIBC) [Day 4]: in the morning before third supplement intake of the 60mg daily vs alternate day cycle
- Total Iron Binding Capacity (TIBC) [Day 1]: in the afternoon after first supplement intake of the 60mg daily vs alternate day cycle
- Total Iron Binding Capacity (TIBC) [Day 18]: in the morning before first supplement intake of the 120mg daily vs alternate day cycle
- Total Iron Binding Capacity (TIBC) [Day 19]: in the morning before second supplement intake of the 120mg daily vs alternate day cycle
- Total Iron Binding Capacity (TIBC) [Day 21]: in the morning before third supplement intake of the 120mg daily vs alternate day cycle
- Total Iron Binding Capacity (TIBC) [Day 18]: in the afternoon after first supplement intake of the 120mg daily vs alternate day cycle
- Total Iron Binding Capacity (TIBC) [Day 35]: in the morning before first supplement intake of the 120mg daily vs every third day cycle
- Total Iron Binding Capacity (TIBC) [Day 36]: in the morning before second supplement intake of the 120mg daily vs every third day cycle
- Total Iron Binding Capacity (TIBC) [Day 39]: in the morning before third supplement intake of the 120mg daily vs every third day cycle
- Total Iron Binding Capacity (TIBC) [Day 53]: in the morning 14 after last supplement intake of the 120mg daily vs every third day cycle
- Total Iron Binding Capacity (TIBC) [Day 53]: in the afternoon 14 after last supplement intake of the 120mg daily vs every third day cycle
+Eligibility
Sex: Female, ages: 18 Years to 45 Years
Inclusion Criteria:
* gestational week 14-16 at study start
* singleton pregnancy
* Serum ferritin SF <60 µg/L
* non-anemic or mildly anemic, defined as hemoglobin (Hb) >10 g/dL
* female aged 18-45 years
* healthy Thai woman
Exclusion Criteria:
* acute or chronic disease
* taking medications that could influence iron absorption
* smoking
+Locations (1)
| Facility | City | Country | Status |
|---|
| Mahidol University | Salaya, Changwat Nakhon Pathom | Thailand | |
+Publications
- Results publication: 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. PMID 37357807