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

Federal Institute of Technology (ETH) Zurich

Status: Completed

Conditions: Iron Deficiency Anemia of Pregnancy

Treatments: Dietary Supplement: Labeled iron solution (60mg and 120mg Ferrous Fumarate)

Study type: Interventional

Funder types: Other

Identifiers

NCT04074707

TIPS

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

oral iron supplementation

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Labeled iron solution (60mg and 120mg Ferrous Fumarate)