Defining a Dosing Regimen With Maximal Absorption for Oral Iron Supplementation During Pregnancy

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

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.

each subject acts as her own control by going through all the three supplementation cycles. Women will be randomly assigned to start with the daily, every other day or every third day supplementation cycle.

Participants go through 3 cycles of oral iron Supplementation (daily dosing, alternate-day dosing, every third-day dosing)

3 doses of 60mg iron as FeSO4 are given on 3 consecutive days (e.g., days 1-3); 3 doses of 120mg iron as FeSO4 are given on one consecutive and one alternate day (e.g., days 20, 21, 23); 3 doses of 120mg iron as FeSO4 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 100ml deionized water (57Fe, 58Fe or 54Fe). Participants will be randomly assigned to start with daily, alternate-day or every-third day dosing.

Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the consecutive day cycle

Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the alternate day cycle

Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the every third day cycle

Inclusion Criteria: gestational week 14-16 singleton pregnancy iron depleted, defined as serum ferritin SF <30 µg/L non-anemic, defined as hemoglobin (Hb) >11g/dL Exclusion Criteria: acute or chronic disease taking medications that could influence iron absorption smoking