Clinical trial NCT04074707: Defining a Dosing Regimen With Maximal Absorption for Oral Iron Supplementation During Pregnancy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency Anemia of Pregnancy
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Mahidol University
First posted: 2019-08-30
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: each subject acts as her own control by going through all the three supplementation cycles. Women will be randomly assigned to start with the 60mg daily vs alternate day, 120mg daily vs alternate day or 120mg daily vs every third day supplementation cycle.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fractional iron absorption in %
timeFrame: Day 18
measure: Fractional iron absorption in %
timeFrame: Day 35
measure: Fractional iron absorption in %
timeFrame: Day 53
measure: Total iron absorption in %
timeFrame: Day 18
measure: Total iron absorption in %
timeFrame: Day 35
measure: Total iron absorption in %
timeFrame: Day 53
measure: Serum Hepcidin
timeFrame: Day 1
measure: Serum Hepcidin
timeFrame: Day 2
measure: Serum Hepcidin
timeFrame: Day 4
measure: Serum Hepcidin
timeFrame: Day 18
measure: Serum Hepcidin
timeFrame: Day 19
measure: Serum Hepcidin
timeFrame: Day 21
measure: Serum Hepcidin
timeFrame: Day 35
measure: Serum Hepcidin
timeFrame: Day 36
measure: Serum Hepcidin
timeFrame: Day 39
measure: Serum Hepcidin
timeFrame: Day 53
Secondary outcomes:
measure: Serum Ferritin (SF)
timeFrame: Screening
measure: Serum Ferritin (SF)
timeFrame: Day 1
measure: Serum Ferritin (SF)
timeFrame: Day 18
measure: Serum Ferritin (SF)
timeFrame: Day 35
measure: Serum Ferritin (SF)
timeFrame: Day 53
measure: Hemoglobin (Hb)
timeFrame: Screening
measure: Hemoglobin (Hb)
timeFrame: Day 1
measure: Hemoglobin (Hb)
timeFrame: Day 18
measure: Hemoglobin (Hb)
timeFrame: Day 35
measure: Hemoglobin (Hb)
timeFrame: Day 53
measure: Soluble transferrin receptor (sTfR)
timeFrame: Day 1
measure: Soluble transferrin receptor (sTfR)
timeFrame: Day 18
measure: Soluble transferrin receptor (sTfR)
timeFrame: Day 35
measure: Soluble transferrin receptor (sTfR)
timeFrame: Day 53
measure: C-reactive protein (CRP)
timeFrame: Day 1
measure: C-reactive protein (CRP)
timeFrame: Day 18
measure: C-reactive protein (CRP)
timeFrame: Day 35
measure: C-reactive protein (CRP)
timeFrame: Day 53
measure: Alpha-1-acid glycoprotein (AGP)
timeFrame: Day 1
measure: Alpha-1-acid glycoprotein (AGP)
timeFrame: Day 18
measure: Alpha-1-acid glycoprotein (AGP)
timeFrame: Day 35
measure: Alpha-1-acid glycoprotein (AGP)
timeFrame: Day 53
measure: Serum Hepcidin
timeFrame: Day 1
measure: Serum Hepcidin
timeFrame: Day 18
measure: Serum Hepcidin
timeFrame: Day 53
measure: Serum Iron (SFe)
timeFrame: Day 1
measure: Serum Iron (SFe)
timeFrame: Day 2
measure: Serum Iron (SFe)
timeFrame: Day 4
measure: Serum Iron (SFe)
timeFrame: Day 1
measure: Serum Iron (SFe)
timeFrame: Day 18
measure: Serum Iron (SFe)
timeFrame: Day 19
measure: Serum Iron (SFe)
timeFrame: Day 21
measure: Serum Iron (SFe)
timeFrame: Day 18
measure: Serum Iron (SFe)
timeFrame: Day 35
measure: Serum Iron (SFe)
timeFrame: Day 36
measure: Serum Iron (SFe)
timeFrame: Day 39
measure: Serum Iron (SFe)
timeFrame: Day 53
measure: Serum Iron (SFe)
timeFrame: Day 53
measure: Total Iron Binding Capacity (TIBC)
timeFrame: Day 1
measure: Total Iron Binding Capacity (TIBC)
timeFrame: Day 2
measure: Total Iron Binding Capacity (TIBC)
timeFrame: Day 4
measure: Total Iron Binding Capacity (TIBC)
timeFrame: Day 1
measure: Total Iron Binding Capacity (TIBC)
timeFrame: Day 18
measure: Total Iron Binding Capacity (TIBC)
timeFrame: Day 19
measure: Total Iron Binding Capacity (TIBC)
timeFrame: Day 21
measure: Total Iron Binding Capacity (TIBC)
timeFrame: Day 18
measure: Total Iron Binding Capacity (TIBC)
timeFrame: Day 35
measure: Total Iron Binding Capacity (TIBC)
timeFrame: Day 36
measure: Total Iron Binding Capacity (TIBC)
timeFrame: Day 39
measure: Total Iron Binding Capacity (TIBC)
timeFrame: Day 53
measure: Total Iron Binding Capacity (TIBC)
timeFrame: Day 53
Other outcomes:
Locations:
city: Salaya
country: Thailand
facility: Mahidol University
state: Nakhon Pathom
Study officials:
References: