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

Iron Deficiency Anemia of Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04074707
• Other study ID #: TIPS
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2019
• Est. completion date: December 2019

Study information

• Verified date: August 2019
• Source: Swiss Federal Institute of Technology
• Contact: Hanna von Siebenthal
• Phone: +41 44 632 53 73
• Email: hanna.vonsiebenthal[@]hest.ethz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• gestational week 14-16

• singleton pregnancy

• iron depleted, defined as serum ferritin SF <30 µg/L

• non-anemic, defined as hemoglobin (Hb) >11g/dL

Exclusion Criteria:

• acute or chronic disease

• taking medications that could influence iron absorption

• smoking

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency Anemia of Pregnancy

Intervention

Dietary Supplement:
• Labeled iron solution (60mg and 120mg Ferrous Sulfate)
3 doses of 60mg iron as FeSO4 are given on 3 consecutive days (e.g., days 1-3); 3 doses of 120mg iron as FeSO4 are given on one consecutive and one alternate day (e.g., days 20, 21, 23); 3 doses of 120mg iron as FeSO4 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 100ml deionized water (57Fe, 58Fe or 54Fe). Participants will be randomly assigned to start with daily, alternate-day or every-third day dosing.

Locations

Country	Name	City	State
Thailand	Mahidol University	Salaya	Nakhon Pathom

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional iron absorption in %	Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the consecutive day cycle	Day 17
Primary	Fractional iron absorption in %	Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the alternate day cycle	Day 34
Primary	Fractional iron absorption in %	Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the every third day cycle	Day 52
Primary	Total iron absorption in %	Fractional iron absorption measured from consecutive day cycle multiplied by the dose	Day 17
Primary	Total iron absorption in %	Fractional iron absorption measured from alternate day cycle multiplied by the dose	Day 34
Primary	Total iron absorption in %	Fractional iron absorption measured from every third day cycle multiplied by the dose	Day 52
Primary	Serum Hepcidin	in the morning a day before first supplement intake of consecutive day cycle	Day 0
Primary	Serum Hepcidin	in the morning before first supplement intake of consecutive day cycle	Day 1
Primary	Serum Hepcidin	in the morning before second supplement intake of consecutive day cycle	Day 2
Primary	Serum Hepcidin	in the morning before third supplement intake of consecutive day cycle	Day 3
Primary	Serum Hepcidin	in the morning before first supplement intake of alternate day cycle	Day 17
Primary	Serum Hepcidin	in the morning before second supplement intake of alternate day cycle	Day 18
Primary	Serum Hepcidin	in the morning before third supplement intake of alternate day cycle	Day 20
Primary	Serum Hepcidin	in the morning before first supplement intake of every third day cycle	Day 34
Primary	Serum Hepcidin	in the morning before second supplement intake of every third day cycle	Day 35
Primary	Serum Hepcidin	in the morning before third supplement intake of every third day cycle	Day 38
Primary	Serum Hepcidin	in the morning 14 days after last supplement intake of every third day cycle	Day 52
Secondary	Serum Ferritin (SF)	in the morning 1 day before first supplement intake of consecutive day cycle	Day 0
Secondary	Serum Ferritin (SF)	in the morning before first supplement intake of consecutive day cycle	Day 1
Secondary	Serum Ferritin (SF)	in the morning before first supplement intake of alternate day cycle	Day 17
Secondary	Serum Ferritin (SF)	in the morning before first supplement intake of every third day cycle	Day 34
Secondary	Serum Ferritin (SF)	in the morning 14 days after last supplement intake of every third day	Day 52
Secondary	Hemoglobin (Hb)	in the morning 1 day before first supplement intake of consecutive day cycle	Day 0
Secondary	Hemoglobin (Hb)	in the morning before first supplement intake of consecutive day cycle	Day 1
Secondary	Hemoglobin (Hb)	in the morning before first supplement intake of alternate day cycle	Day 17
Secondary	Hemoglobin (Hb)	in the morning before first supplement intake of every third day cycle	Day 34
Secondary	Hemoglobin (Hb)	in the morning 14 days after last supplement intake of every third day cycle	Day 52
Secondary	Soluble transferrin receptor (sTfR)	in the morning 1 day before first supplement intake of consecutive day cycle	Day 0
Secondary	Soluble transferrin receptor (sTfR)	in the morning before first supplement intake of consecutive day cycle	Day 1
Secondary	Soluble transferrin receptor (sTfR)	in the morning before first supplement intake of alternate day cycle	Day 17
Secondary	Soluble transferrin receptor (sTfR)	in the morning before first supplement intake of every third day cycle	Day 34
Secondary	Soluble transferrin receptor (sTfR)	in the morning 14 days after last supplement intake of every third day cycle	Day 52
Secondary	C-reactive protein (CRP)	in the morning 1 day before first supplement intake of consecutive day cycle	Day 0
Secondary	C-reactive protein (CRP)	in the morning before first supplement intake of consecutive day cycle	Day 1
Secondary	C-reactive protein (CRP)	in the morning before first supplement intake of alternate day cycle	Day 17
Secondary	C-reactive protein (CRP)	in the morning before first supplement intake of every third day cycle	Day 34
Secondary	C-reactive protein (CRP)	in the morning 14 days after last supplement intake of every third day cycle	Day 52
Secondary	Alpha-1-acid glycoprotein (AGP)	in the morning 1 day before first supplement intake of consecutive day cycle	Day 0
Secondary	Alpha-1-acid glycoprotein (AGP)	in the morning before first supplement intake of consecutive day cycle	Day 1
Secondary	Alpha-1-acid glycoprotein (AGP)	in the morning before first supplement intake of alternate day cycle	Day 17
Secondary	Alpha-1-acid glycoprotein (AGP)	in the morning before first supplement intake of every third day cycle	Day 34
Secondary	Alpha-1-acid glycoprotein (AGP)	in the morning 14 days after last supplement intake of every third day cycle	Day 52
Secondary	Serum Hepcidin	in the afternoon a day before first supplement intake of consecutive day cycle	Day 0
Secondary	Serum Hepcidin	in the afternoon after first supplement intake of consecutive day cycle	Day 1
Secondary	Serum Hepcidin	in the afternoon after second supplement intake of consecutive day cycle	Day 2
Secondary	Serum Hepcidin	in the afternoon after third supplement intake of consecutive day cycle	Day 3
Secondary	Serum Hepcidin	in the afternoon after first supplement intake of alternate day cycle	Day 17
Secondary	Serum Hepcidin	in the afternoon after second supplement intake of alternate day cycle	Day 18
Secondary	Serum Hepcidin	in the afternoon after third supplement intake of alternate day cycle	Day 20
Secondary	Serum Hepcidin	in the afternoon after first supplement intake of every third day cycle	Day 34
Secondary	Serum Hepcidin	in the afternoon after second supplement intake of every third day cycle	Day 35
Secondary	Serum Hepcidin	in the afternoon after third supplement intake of every third day cycle	Day 38
Secondary	Serum Hepcidin	in the afternoon 14 days after third supplement intake of every third day cycle	Day 52