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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-24

Study Completion Date

2022-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Iron Deficiency Anemia of Pregnancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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oral iron supplementation

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)

Group Type EXPERIMENTAL

Labeled iron solution (60mg and 120mg Ferrous Fumarate)

Intervention Type 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.

Interventions

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Labeled 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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