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

Swiss Federal Institute of Technology30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Iron Deficiency Anemia of Pregnancy

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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)

Mahidol University

Salaya, Changwat Nakhon Pathom, Thailand

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Day 53

Total iron absorption in %

Fractional iron absorption measured from the 60mg daily vs alternate day cycle multiplied by the dose

Time frame: Day 18

Total iron absorption in %

Fractional iron absorption measured from the 120mg daily vs alternate day cycle multiplied by the dose

Time frame: Day 35

Total iron absorption in %

Fractional iron absorption measured from the 120mg daily vs every third day cycle multiplied by the dose

Time frame: Day 53

Serum Hepcidin

in the morning before first supplement intake of the 60mg daily vs alternate day cycle

Time frame: Day 1

Serum Hepcidin

in the morning before second supplement intake of the 60mg daily vs alternate day cycle

Time frame: Day 2

Serum Hepcidin

in the morning before third supplement intake of the 60mg daily vs alternate day cycle

Time frame: Day 4

Serum Hepcidin

in the morning before first supplement intake of 120mg daily vs alternate day cycle

Time frame: Day 18

Serum Hepcidin

in the morning before second supplement intake of 120mg daily vs alternate day cycle

Time frame: Day 19

Serum Hepcidin

in the morning before third supplement intake of 120mg daily vs alternate day cycle

Time frame: Day 21

Serum Hepcidin

in the morning before first supplement intake of the 120mg daily vs every third day cycle

Time frame: Day 35

Serum Hepcidin

in the morning before second supplement intake of the 120mg daily vs every third day cycle

Time frame: Day 36

Serum Hepcidin

in the morning before third supplement intake of the 120mg daily vs every third day cycle

Time frame: Day 39

Serum Hepcidin

in the morning 14 days after last supplement intake the 120mg daily vs every third day cycle

Time frame: Day 53

Secondary Outcomes

Serum Ferritin (SF)

in the morning before first supplement intake

Time frame: Screening

Serum Ferritin (SF)

in the morning before first supplement intake of the 60mg daily vs alternate day cycle

Time frame: Day 1

Serum Ferritin (SF)

in the morning before first supplement intake of the 120mg daily vs alternate day cycle

Time frame: Day 18

Serum Ferritin (SF)

in the morning before first supplement intake of the 120mg daily vs every third day cycle

Time frame: Day 35

Serum Ferritin (SF)

in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle

Time frame: Day 53

Hemoglobin (Hb)

in the morning before first supplement intake

Time frame: Screening

Hemoglobin (Hb)

in the morning before first supplement intake of the 60mg daily vs alternate day cycle

Time frame: Day 1

Hemoglobin (Hb)

in the morning before first supplement intake of the 120mg daily vs alternate day cycle

Time frame: Day 18

Hemoglobin (Hb)

in the morning before first supplement intake of the 120mg daily vs every third day cycle

Time frame: Day 35

Hemoglobin (Hb)

Data from ClinicalTrials.gov

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in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle

Soluble transferrin receptor (sTfR)

in the morning before first supplement intake of the 60mg daily vs alternate day cycle

Time frame: Day 1

Soluble transferrin receptor (sTfR)

in the morning before first supplement intake of the 120mg daily vs alternate day cycle

Time frame: Day 18

Soluble transferrin receptor (sTfR)

in the morning before first supplement intake of the 120mg daily vs every third day cycle

Time frame: Day 35

Soluble transferrin receptor (sTfR)

in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle

Time frame: Day 53

C-reactive protein (CRP)

in the morning before first supplement intake of the 60mg daily vs alternate day cycle

Time frame: Day 1

C-reactive protein (CRP)

in the morning before first supplement intake of the 120mg daily vs alternate day cycle

Time frame: Day 18

C-reactive protein (CRP)

in the morning before first supplement intake of the 120mg daily vs every third day cycle

Time frame: Day 35

C-reactive protein (CRP)

in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle

Time frame: Day 53

Alpha-1-acid glycoprotein (AGP)

in the morning before first supplement intake of the 60mg daily vs alternate day cycle

Time frame: Day 1

Alpha-1-acid glycoprotein (AGP)

in the morning before first supplement intake of the 120mg daily vs alternate day cycle

Time frame: Day 18

Alpha-1-acid glycoprotein (AGP)

in the morning before first supplement intake of the 120mg daily vs every third day cycle

Time frame: 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

Time frame: Day 53

Serum Hepcidin

in the afternoon after first supplement intake of the 60mg daily vs alternate day cycle

Time frame: Day 1

Serum Hepcidin

in the afternoon after first supplement intake of the 120mg daily vs alternate day cycle

Time frame: Day 18

Serum Hepcidin

in the afternoon 14 days after third supplement intake of the 120mg daily vs every third day cycle

Time frame: Day 53

Serum Iron (SFe)

in the morning before first supplement intake of the 60mg daily vs alternate day cycle

Time frame: Day 1

Serum Iron (SFe)

in the morning before second supplement intake of the 60mg daily vs alternate day cycle

Time frame: Day 2

Serum Iron (SFe)

in the morning before third supplement intake of the 60mg daily vs alternate day cycle

Time frame: Day 4

Serum Iron (SFe)

in the afternoon after first supplement intake of the 60mg daily vs alternate day cycle

Time frame: Day 1

Serum Iron (SFe)

in the morning before the first supplement intake of the 120mg daily vs alternate day cycle

Time frame: Day 18

Serum Iron (SFe)

in the morning before the second supplement intake of the 120mg daily vs alternate day cycle

Time frame: Day 19

Serum Iron (SFe)

in the morning before the third supplement intake of the 120mg daily vs alternate day cycle

Time frame: Day 21

Serum Iron (SFe)

in the afternoon after the first supplement intake of the 120mg daily vs alternate day cycle

Time frame: Day 18

Serum Iron (SFe)

in the morning before the first supplement intake of the 120mg daily vs every third day cycle

Time frame: Day 35

Serum Iron (SFe)

in the morning before the second supplement intake of the 120mg daily vs every third day cycle

Time frame: Day 36

Serum Iron (SFe)

in the morning before the third supplement intake of the 120mg daily vs every third day cycle

Time frame: Day 39

Serum Iron (SFe)

in the morning 14 days after the last supplement intake of the 120mg daily vs every third day cycle

Time frame: Day 53

Serum Iron (SFe)

in the afternoon 14 days after the last supplement intake of the 120mg daily vs every third day cycle

Time frame: Day 53