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

July 23, 2024 updated by: Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Thailand
    • Nakhon Pathom
      • Salaya, Nakhon Pathom, Thailand, 73170
        • Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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)
Dietary supplement: Labeled iron solution (60mg and 120mg Ferrous Fumarate)
3 doses of 60mg iron as ferrous fumarate are given on one consecutive day and one alternate day (e.g., days 1, 2, 4); 3 doses of 120mg iron as ferrous fumarate are given on one consecutive and one alternate day (e.g., days 20, 21, 23); 3 doses of 120mg iron as ferrous fumarate 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 200ml deionized water (57Fe, 58Fe or 54Fe). Participants will be randomly assigned to start with 60mg iron daily vs alternate day dosing, 120mg daily vs alternate day dosing or 120mg daily vs every-third day dosing.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Day 18
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
Day 35
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
Day 53
Total iron absorption in %
Time Frame: Day 18
Fractional iron absorption measured from the 60mg daily vs alternate day cycle multiplied by the dose
Day 18
Total iron absorption in %
Time Frame: Day 35
Fractional iron absorption measured from the 120mg daily vs alternate day cycle multiplied by the dose
Day 35
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
Day 53
Serum Hepcidin
Time Frame: Day 1
in the morning before first supplement intake of the 60mg daily vs alternate day cycle
Day 1
Serum Hepcidin
Time Frame: Day 2
in the morning before second supplement intake of the 60mg daily vs alternate day cycle
Day 2
Serum Hepcidin
Time Frame: Day 4
in the morning before third supplement intake of the 60mg daily vs alternate day cycle
Day 4
Serum Hepcidin
Time Frame: Day 18
in the morning before first supplement intake of 120mg daily vs alternate day cycle
Day 18
Serum Hepcidin
Time Frame: Day 19
in the morning before second supplement intake of 120mg daily vs alternate day cycle
Day 19
Serum Hepcidin
Time Frame: Day 21
in the morning before third supplement intake of 120mg daily vs alternate day cycle
Day 21
Serum Hepcidin
Time Frame: Day 35
in the morning before first supplement intake of the 120mg daily vs every third day cycle
Day 35
Serum Hepcidin
Time Frame: Day 36
in the morning before second supplement intake of the 120mg daily vs every third day cycle
Day 36
Serum Hepcidin
Time Frame: Day 39
in the morning before third supplement intake of the 120mg daily vs every third day cycle
Day 39
Serum Hepcidin
Time Frame: Day 53
in the morning 14 days after last supplement intake the 120mg daily vs every third day cycle
Day 53

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum Ferritin (SF)
Time Frame: Screening
in the morning before first supplement intake
Screening
Serum Ferritin (SF)
Time Frame: Day 1
in the morning before first supplement intake of the 60mg daily vs alternate day cycle
Day 1
Serum Ferritin (SF)
Time Frame: Day 18
in the morning before first supplement intake of the 120mg daily vs alternate day cycle
Day 18
Serum Ferritin (SF)
Time Frame: Day 35
in the morning before first supplement intake of the 120mg daily vs every third day cycle
Day 35
Serum Ferritin (SF)
Time Frame: Day 53
in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle
Day 53
Hemoglobin (Hb)
Time Frame: Screening
in the morning before first supplement intake
Screening
Hemoglobin (Hb)
Time Frame: Day 1
in the morning before first supplement intake of the 60mg daily vs alternate day cycle
Day 1
Hemoglobin (Hb)
Time Frame: Day 18
in the morning before first supplement intake of the 120mg daily vs alternate day cycle
Day 18
Hemoglobin (Hb)
Time Frame: Day 35
in the morning before first supplement intake of the 120mg daily vs every third day cycle
Day 35
Hemoglobin (Hb)
Time Frame: Day 53
in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle
Day 53
Soluble transferrin receptor (sTfR)
Time Frame: Day 1
in the morning before first supplement intake of the 60mg daily vs alternate day cycle
Day 1
Soluble transferrin receptor (sTfR)
Time Frame: Day 18
in the morning before first supplement intake of the 120mg daily vs alternate day cycle
Day 18
Soluble transferrin receptor (sTfR)
Time Frame: Day 35
in the morning before first supplement intake of the 120mg daily vs every third day cycle
Day 35
Soluble transferrin receptor (sTfR)
Time Frame: Day 53
in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle
Day 53
C-reactive protein (CRP)
Time Frame: Day 1
in the morning before first supplement intake of the 60mg daily vs alternate day cycle
Day 1
C-reactive protein (CRP)
Time Frame: Day 18
in the morning before first supplement intake of the 120mg daily vs alternate day cycle
Day 18
C-reactive protein (CRP)
Time Frame: Day 35
in the morning before first supplement intake of the 120mg daily vs every third day cycle
Day 35
C-reactive protein (CRP)
Time Frame: Day 53
in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle
Day 53
Alpha-1-acid glycoprotein (AGP)
Time Frame: Day 1
in the morning before first supplement intake of the 60mg daily vs alternate day cycle
Day 1
Alpha-1-acid glycoprotein (AGP)
Time Frame: Day 18
in the morning before first supplement intake of the 120mg daily vs alternate day cycle
Day 18
Alpha-1-acid glycoprotein (AGP)
Time Frame: Day 35
in the morning before first supplement intake of the 120mg daily vs every third day cycle
Day 35
Alpha-1-acid glycoprotein (AGP)
Time Frame: Day 53
in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle
Day 53
Serum Hepcidin
Time Frame: Day 1
in the afternoon after first supplement intake of the 60mg daily vs alternate day cycle
Day 1
Serum Hepcidin
Time Frame: Day 18
in the afternoon after first supplement intake of the 120mg daily vs alternate day cycle
Day 18
Serum Hepcidin
Time Frame: Day 53
in the afternoon 14 days after third supplement intake of the 120mg daily vs every third day cycle
Day 53
Serum Iron (SFe)
Time Frame: Day 1
in the morning before first supplement intake of the 60mg daily vs alternate day cycle
Day 1
Serum Iron (SFe)
Time Frame: Day 2
in the morning before second supplement intake of the 60mg daily vs alternate day cycle
Day 2
Serum Iron (SFe)
Time Frame: Day 4
in the morning before third supplement intake of the 60mg daily vs alternate day cycle
Day 4
Serum Iron (SFe)
Time Frame: Day 1
in the afternoon after first supplement intake of the 60mg daily vs alternate day cycle
Day 1
Serum Iron (SFe)
Time Frame: Day 18
in the morning before the first supplement intake of the 120mg daily vs alternate day cycle
Day 18
Serum Iron (SFe)
Time Frame: Day 19
in the morning before the second supplement intake of the 120mg daily vs alternate day cycle
Day 19
Serum Iron (SFe)
Time Frame: Day 21
in the morning before the third supplement intake of the 120mg daily vs alternate day cycle
Day 21
Serum Iron (SFe)
Time Frame: Day 18
in the afternoon after the first supplement intake of the 120mg daily vs alternate day cycle
Day 18
Serum Iron (SFe)
Time Frame: Day 35
in the morning before the first supplement intake of the 120mg daily vs every third day cycle
Day 35
Serum Iron (SFe)
Time Frame: Day 36
in the morning before the second supplement intake of the 120mg daily vs every third day cycle
Day 36
Serum Iron (SFe)
Time Frame: Day 39
in the morning before the third supplement intake of the 120mg daily vs every third day cycle
Day 39
Serum Iron (SFe)
Time Frame: Day 53
in the morning 14 days after the last supplement intake of the 120mg daily vs every third day cycle
Day 53
Serum Iron (SFe)
Time Frame: Day 53
in the afternoon 14 days after the last supplement intake of the 120mg daily vs every third day cycle
Day 53
Total Iron Binding Capacity (TIBC)
Time Frame: Day 1
in the morning before first supplement intake of the 60mg daily vs alternate day cycle
Day 1
Total Iron Binding Capacity (TIBC)
Time Frame: Day 2
in the morning before second supplement intake of the 60mg daily vs alternate day cycle
Day 2
Total Iron Binding Capacity (TIBC)
Time Frame: Day 4
in the morning before third supplement intake of the 60mg daily vs alternate day cycle
Day 4
Total Iron Binding Capacity (TIBC)
Time Frame: Day 1
in the afternoon after first supplement intake of the 60mg daily vs alternate day cycle
Day 1
Total Iron Binding Capacity (TIBC)
Time Frame: Day 18
in the morning before first supplement intake of the 120mg daily vs alternate day cycle
Day 18
Total Iron Binding Capacity (TIBC)
Time Frame: Day 19
in the morning before second supplement intake of the 120mg daily vs alternate day cycle
Day 19
Total Iron Binding Capacity (TIBC)
Time Frame: Day 21
in the morning before third supplement intake of the 120mg daily vs alternate day cycle
Day 21
Total Iron Binding Capacity (TIBC)
Time Frame: Day 18
in the afternoon after first supplement intake of the 120mg daily vs alternate day cycle
Day 18
Total Iron Binding Capacity (TIBC)
Time Frame: Day 35
in the morning before first supplement intake of the 120mg daily vs every third day cycle
Day 35
Total Iron Binding Capacity (TIBC)
Time Frame: Day 36
in the morning before second supplement intake of the 120mg daily vs every third day cycle
Day 36
Total Iron Binding Capacity (TIBC)
Time Frame: Day 39
in the morning before third supplement intake of the 120mg daily vs every third day cycle
Day 39
Total Iron Binding Capacity (TIBC)
Time Frame: Day 53
in the morning 14 after last supplement intake of the 120mg daily vs every third day cycle
Day 53
Total Iron Binding Capacity (TIBC)
Time Frame: Day 53
in the afternoon 14 after last supplement intake of the 120mg daily vs every third day cycle
Day 53

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swiss Federal Institute of Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 24, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TIPS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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