MedTrace Logo

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

NCT04074707 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-07-24

No results posted yet for this study

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.

Conditions

  • Iron Deficiency Anemia of Pregnancy

Interventions

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

  • Mahidol University

    collaborator OTHER

  • Swiss Federal Institute of Technology

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-24
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Thailand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04074707 on ClinicalTrials.gov