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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Serum Hepcidin
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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)
Intervention: Labeled iron solution (60mg and 120mg Ferrous Fumarate) (Dietary Supplement)
Outcomes
Primary Outcomes
Serum Hepcidin
Time Frame: Day 53
in the morning 14 days after last supplement intake the 120mg daily vs every third day cycle
Total iron absorption in %
Time Frame: Day 53
Fractional iron absorption measured from the 120mg daily vs every third day cycle multiplied by the dose
Fractional iron absorption in %
Time Frame: Day 53
Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the 120mg daily vs every third day cycle
Fractional iron absorption in %
Time Frame: Day 18
Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the 60mg daily vs alternate day cycle
Fractional iron absorption in %
Time Frame: Day 35
Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the 120mg daily vs alternate day cycle
Total iron absorption in %
Time Frame: Day 18
Fractional iron absorption measured from the 60mg daily vs alternate day cycle multiplied by the dose
Total iron absorption in %
Time Frame: Day 35
Fractional iron absorption measured from the 120mg daily vs alternate day cycle multiplied by the dose
Serum Hepcidin
Time Frame: Day 1
in the morning before first supplement intake of the 60mg daily vs alternate day cycle
Serum Hepcidin
Time Frame: Day 2
in the morning before second supplement intake of the 60mg daily vs alternate day cycle
Serum Hepcidin
Time Frame: Day 4
in the morning before third supplement intake of the 60mg daily vs alternate day cycle
Serum Hepcidin
Time Frame: Day 18
in the morning before first supplement intake of 120mg daily vs alternate day cycle
Serum Hepcidin
Time Frame: Day 19
in the morning before second supplement intake of 120mg daily vs alternate day cycle
Serum Hepcidin
Time Frame: Day 21
in the morning before third supplement intake of 120mg daily vs alternate day cycle
Serum Hepcidin
Time Frame: Day 35
in the morning before first supplement intake of the 120mg daily vs every third day cycle
Serum Hepcidin
Time Frame: Day 36
in the morning before second supplement intake of the 120mg daily vs every third day cycle
Serum Hepcidin
Time Frame: Day 39
in the morning before third supplement intake of the 120mg daily vs every third day cycle
Secondary Outcomes
- C-reactive protein (CRP)(Day 53)
- Total Iron Binding Capacity (TIBC)(Day 53)
- Serum Iron (SFe)(Day 53)
- Hemoglobin (Hb)(Day 53)
- Soluble transferrin receptor (sTfR)(Day 53)
- Alpha-1-acid glycoprotein (AGP)(Day 53)
- Serum Hepcidin(Day 53)
- Serum Ferritin (SF)(Day 53)
- Serum Ferritin (SF)(Screening)
- Serum Ferritin (SF)(Day 1)
- Serum Ferritin (SF)(Day 18)
- Serum Ferritin (SF)(Day 35)
- Hemoglobin (Hb)(Screening)
- Hemoglobin (Hb)(Day 1)
- Hemoglobin (Hb)(Day 18)
- Hemoglobin (Hb)(Day 35)
- Soluble transferrin receptor (sTfR)(Day 1)
- Soluble transferrin receptor (sTfR)(Day 18)
- Soluble transferrin receptor (sTfR)(Day 35)
- C-reactive protein (CRP)(Day 1)
- C-reactive protein (CRP)(Day 18)
- C-reactive protein (CRP)(Day 35)
- Alpha-1-acid glycoprotein (AGP)(Day 1)
- Alpha-1-acid glycoprotein (AGP)(Day 18)
- Alpha-1-acid glycoprotein (AGP)(Day 35)
- Serum Hepcidin(Day 1)
- Serum Hepcidin(Day 18)
- Serum Iron (SFe)(Day 1)
- Serum Iron (SFe)(Day 2)
- Serum Iron (SFe)(Day 4)
- Serum Iron (SFe)(Day 18)
- Serum Iron (SFe)(Day 19)
- Serum Iron (SFe)(Day 21)
- Serum Iron (SFe)(Day 35)
- Serum Iron (SFe)(Day 36)
- Serum Iron (SFe)(Day 39)
- Total Iron Binding Capacity (TIBC)(Day 1)
- Total Iron Binding Capacity (TIBC)(Day 2)
- Total Iron Binding Capacity (TIBC)(Day 4)
- Total Iron Binding Capacity (TIBC)(Day 18)
- Total Iron Binding Capacity (TIBC)(Day 19)
- Total Iron Binding Capacity (TIBC)(Day 21)
- Total Iron Binding Capacity (TIBC)(Day 35)
- Total Iron Binding Capacity (TIBC)(Day 36)
- Total Iron Binding Capacity (TIBC)(Day 39)
Investigators
Prof. Michael B. Zimmermann
Prof.Dr.
Swiss Federal Institute of Technology