Iron Deficiency Anemia of Pregnancy
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTLabeled iron solution (60mg and 120mg Ferrous Fumarate)
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.
Sponsors
Mahidol University
Swiss Federal Institute of Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Hepcidin | Day 1 | in the morning before first supplement intake of the 60mg daily vs alternate day cycle |
| 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 |
| Total iron absorption in % | Day 18 | Fractional iron absorption measured from the 60mg daily vs alternate day cycle multiplied by the dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-reactive protein (CRP) | Day 1 | in the morning before first supplement intake of the 60mg daily vs alternate day cycle |
| Alpha-1-acid glycoprotein (AGP) | Day 1 | in the morning before first supplement intake of the 60mg daily vs alternate day cycle |
| Serum Ferritin (SF) | Screening | in the morning before first supplement intake |
| Serum Iron (SFe) | Day 1 | in the morning before first supplement intake of the 60mg daily vs alternate day cycle |
| Total Iron Binding Capacity (TIBC) | Day 1 | in the morning before first supplement intake of the 60mg daily vs alternate day cycle |
| Serum Hepcidin | Day 1 | in the afternoon after first supplement intake of the 60mg daily vs alternate day cycle |
| Hemoglobin (Hb) | Screening | in the morning before first supplement intake |
| Soluble transferrin receptor (sTfR) | Day 1 | in the morning before first supplement intake of the 60mg daily vs alternate day cycle |
Countries
Thailand
Outcome results
None listed