Defining a Dosing Regimen With Maximal Absorption for Oral Iron Supplementation During Pregnancy
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Interventions
- Dietary Supplement: Labeled iron solution (60mg and 120mg Ferrous Fumarate)
- Registration Number
- NCT04074707
- Lead Sponsor
- Swiss Federal Institute of Technology
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
- 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
- acute or chronic disease
- taking medications that could influence iron absorption
- smoking
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description oral iron supplementation Labeled iron solution (60mg and 120mg Ferrous Fumarate) 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)
- Primary Outcome Measures
Name Time Method Total iron absorption in % Day 53 Fractional iron absorption measured from the 120mg daily vs every third day cycle multiplied by the dose
Fractional iron absorption in % Day 53 Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the 120mg daily vs every third day cycle
Serum Hepcidin Day 53 in the morning 14 days after last supplement intake the 120mg daily vs every third day cycle
- Secondary Outcome Measures
Name Time Method Hemoglobin (Hb) Day 53 in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle
Soluble transferrin receptor (sTfR) Day 53 in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle
Alpha-1-acid glycoprotein (AGP) Day 53 in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle
Serum Hepcidin Day 53 in the afternoon 14 days after third supplement intake of the 120mg daily vs every third day cycle
Serum Ferritin (SF) Day 53 in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle
C-reactive protein (CRP) Day 53 in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle
Total Iron Binding Capacity (TIBC) Day 53 in the afternoon 14 after last supplement intake of the 120mg daily vs every third day cycle
Serum Iron (SFe) Day 53 in the afternoon 14 days after the last supplement intake of the 120mg daily vs every third day cycle
Trial Locations
- Locations (1)
Mahidol University
🇹🇭Salaya, Nakhon Pathom, Thailand