NCT04074707

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Swiss Federal Institute of Technology · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-10-24
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2019-08-30
• Last updated: 2024-07-24

Locations

1 site across 1 country: Thailand