Assessing the Immediate Increase in Serum Ferritin After Oral Iron Doses: an Experimental Study in Iron-deficient Women (INFER 2)

May 19, 2025 updated by: Swiss Federal Institute of Technology
Serum ferritin is a key indicator of body iron stores and is widely used in monitoring iron status. However, oral iron doses can acutely elevate SF levels, potentially biasing assessments of iron stores during supplementation. This study aims to investigate the extent and duration of the acute iron-induced effect on serum ferritin following the administration of a daily iron dose for two months.

Study Overview

Status

Status

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

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 (Estimated)

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.
120

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

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Low iron stores (SF levels < 30 µg/L),
  • no anemia (Hb > 120 g/L)
  • no inflammation (CRP < 5 mg/L)
  • 18 to 45 years old.
  • Body weight <70 kg
  • Normal body Mass Index (18.5-26.5 kg/m2)

Exclusion Criteria:

  • Any chronic or acute disease
  • Consumption of mineral and vitamin supplements since screening and over the study period
  • Blood transfusion, blood donation or significant blood loss over the past 4 months,
  • Pregnant or breastfeeding,
  • Continuous/long-term use of medication during the whole studies (except for contraceptives)
  • Therapeutic iron infusion over the past 6 months,
  • Known hypersensitivity or allergy to iron supplements,
  • Intention to become pregnant over the course of the study

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: Randomized
  • Interventional Model: Parallel 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: 80 mg
Daily dose of 80 mg of iron for 1 month, with a 7-day break, then again for another month (2 months total).
Dietary supplement: ferrous sulfate 80 mg
1 tablet per day
Experimental: 160
Daily dose of 160 mg of iron for 1 month, with a 7-day break, then again for another month (2 months total).
Dietary supplement: ferrous sulfate 160 mg
2 tablets per day

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
Serum ferritin
Time Frame: Study day 31
Serum ferritin concentration
Study day 31
Serum ferritin
Time Frame: Study day 37
Serum ferritin concentration
Study day 37
Serum ferritin
Time Frame: Study day 68
Serum ferritin concentration
Study day 68
Serum ferritin
Time Frame: Study day 74
Serum ferritin concentration
Study day 74

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
C-reactive protein
Time Frame: Study day 1
C-reactive protein concentration in serum
Study day 1
alpha(1)-acid-glycoprotein
Time Frame: Study day 1
alpha(1)-acid-glycoprotein concentration in serum
Study day 1
Serum ferritin
Time Frame: Study day 30
Serum ferritin concentration
Study day 30
Serum ferritin
Time Frame: Study day 67
Serum ferritin concentration
Study day 67
Serum ferritin
Time Frame: Study day 20
Serum ferritin concentration
Study day 20
Serum ferritin
Time Frame: Study day 36
Serum ferritin concentration
Study day 36
Serum ferritin
Time Frame: Study day 57
Serum ferritin concentration
Study day 57
Serum ferritin
Time Frame: Study day 72
Serum ferritin concentration
Study day 72
Serum ferritin
Time Frame: Study day 71
Serum ferritin concentration
Study day 71
Serum ferritin
Time Frame: Study day 70
Serum ferritin concentration
Study day 70
Serum ferritin
Time Frame: Study day 69
Serum ferritin concentration
Study day 69
Serum ferritin
Time Frame: Study day 73
Serum ferritin concentration
Study day 73
Serum ferritin
Time Frame: Study day 47
Serum ferritin concentration
Study day 47
Serum ferritin
Time Frame: Study day 35
Serum ferritin concentration
Study day 35
Serum ferritin
Time Frame: Study day 34
Serum ferritin concentration
Study day 34
Serum ferritin
Time Frame: Study day 33
Serum ferritin concentration
Study day 33
Serum ferritin
Time Frame: Study day 32
Serum ferritin concentration
Study day 32
Serum ferritin
Time Frame: Study day 10
Serum ferritin concentration
Study day 10
Serum ferritin
Time Frame: Study day 6
Serum ferritin concentration
Study day 6
Serum ferritin
Time Frame: Study day 3
Serum ferritin concentration
Study day 3
Serum Ferritin
Time Frame: Study Day 1
Serum Ferritin concentration
Study Day 1
Hemoglobin
Time Frame: Study day 1
Hemoglobin concentration
Study day 1
C-reactive protein
Time Frame: Study day 3
C-reactive protein concentration in serum
Study day 3
C-reactive protein
Time Frame: Study day 6
C-reactive protein concentration in serum
Study day 6
C-reactive protein
Time Frame: Study day 10
C-reactive protein concentration in serum
Study day 10
C-reactive protein
Time Frame: Study day 20
C-reactive protein concentration in serum
Study day 20
C-reactive protein
Time Frame: Study day 30
C-reactive protein concentration in serum
Study day 30
C-reactive protein
Time Frame: Study day 31
C-reactive protein concentration in serum
Study day 31
C-reactive protein
Time Frame: Study day 32
C-reactive protein concentration in serum
Study day 32
C-reactive protein
Time Frame: Study day 33
C-reactive protein concentration in serum
Study day 33
C-reactive protein
Time Frame: Study day 34
C-reactive protein concentration in serum
Study day 34
C-reactive protein
Time Frame: Study day 35
C-reactive protein concentration in serum
Study day 35
C-reactive protein
Time Frame: Study day 36
C-reactive protein concentration in serum
Study day 36
C-reactive protein
Time Frame: Study day 37
C-reactive protein concentration in serum
Study day 37
C-reactive protein
Time Frame: Study day 47
C-reactive protein concentration in serum
Study day 47
C-reactive protein
Time Frame: Study day 57
C-reactive protein concentration in serum
Study day 57
C-reactive protein
Time Frame: Study day 67
C-reactive protein concentration in serum
Study day 67
C-reactive protein
Time Frame: Study day 68
C-reactive protein concentration in serum
Study day 68
C-reactive protein
Time Frame: Study day 69
C-reactive protein concentration in serum
Study day 69
C-reactive protein
Time Frame: Study day 70
C-reactive protein concentration in serum
Study day 70
C-reactive protein
Time Frame: Study day 71
C-reactive protein concentration in serum
Study day 71
C-reactive protein
Time Frame: Study day 72
C-reactive protein concentration in serum
Study day 72
C-reactive protein
Time Frame: Study day 73
C-reactive protein concentration in serum
Study day 73
C-reactive protein
Time Frame: Study day 74
C-reactive protein concentration in serum
Study day 74
alpha(1)-acid-glycoprotein
Time Frame: Study day 3
alpha(1)-acid-glycoprotein concentration in serum
Study day 3
alpha(1)-acid-glycoprotein
Time Frame: Study day 6
alpha(1)-acid-glycoprotein concentration in serum
Study day 6
alpha(1)-acid-glycoprotein
Time Frame: Study day 10
alpha(1)-acid-glycoprotein concentration in serum
Study day 10
alpha(1)-acid-glycoprotein
Time Frame: Study day 20
alpha(1)-acid-glycoprotein concentration in serum
Study day 20
alpha(1)-acid-glycoprotein
Time Frame: Study day 30
alpha(1)-acid-glycoprotein concentration in serum
Study day 30
alpha(1)-acid-glycoprotein
Time Frame: Study day 31
alpha(1)-acid-glycoprotein concentration in serum
Study day 31
alpha(1)-acid-glycoprotein
Time Frame: Study day 32
alpha(1)-acid-glycoprotein concentration in serum
Study day 32
alpha(1)-acid-glycoprotein
Time Frame: Study day 33
alpha(1)-acid-glycoprotein concentration in serum
Study day 33
alpha(1)-acid-glycoprotein
Time Frame: Study day 34
alpha(1)-acid-glycoprotein concentration in serum
Study day 34
alpha(1)-acid-glycoprotein
Time Frame: Study day 35
alpha(1)-acid-glycoprotein concentration in serum
Study day 35
alpha(1)-acid-glycoprotein
Time Frame: Study day 36
alpha(1)-acid-glycoprotein concentration in serum
Study day 36
alpha(1)-acid-glycoprotein
Time Frame: Study day 37
alpha(1)-acid-glycoprotein concentration in serum
Study day 37
alpha(1)-acid-glycoprotein
Time Frame: Study day 47
alpha(1)-acid-glycoprotein concentration in serum
Study day 47
alpha(1)-acid-glycoprotein
Time Frame: Study day 57
alpha(1)-acid-glycoprotein concentration in serum
Study day 57
alpha(1)-acid-glycoprotein
Time Frame: Study day 67
alpha(1)-acid-glycoprotein concentration in serum
Study day 67
alpha(1)-acid-glycoprotein
Time Frame: Study day 68
alpha(1)-acid-glycoprotein concentration in serum
Study day 68
alpha(1)-acid-glycoprotein
Time Frame: Study day 69
alpha(1)-acid-glycoprotein concentration in serum
Study day 69
alpha(1)-acid-glycoprotein
Time Frame: Study day 70
alpha(1)-acid-glycoprotein concentration in serum
Study day 70
alpha(1)-acid-glycoprotein
Time Frame: Study day 71
alpha(1)-acid-glycoprotein concentration in serum
Study day 71
alpha(1)-acid-glycoprotein
Time Frame: Study day 72
alpha(1)-acid-glycoprotein concentration in serum
Study day 72
alpha(1)-acid-glycoprotein
Time Frame: Study day 73
alpha(1)-acid-glycoprotein concentration in serum
Study day 73
alpha(1)-acid-glycoprotein
Time Frame: Study day 74
alpha(1)-acid-glycoprotein concentration in serum
Study day 74
Hemoglobin
Time Frame: Study day 10
Hemoglobin concentration
Study day 10
Hemoglobin
Time Frame: Study day 20
Hemoglobin concentration
Study day 20
Hemoglobin
Time Frame: Study day 30
Hemoglobin concentration
Study day 30
Hemoglobin
Time Frame: Study day 37
Hemoglobin concentration
Study day 37
Hemoglobin
Time Frame: Study day 47
Hemoglobin concentration
Study day 47
Hemoglobin
Time Frame: Study day 57
Hemoglobin concentration
Study day 57
Hemoglobin
Time Frame: Study day 67
Hemoglobin concentration
Study day 67
Hemoglobin
Time Frame: Study day 74
Hemoglobin concentration
Study day 74

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

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.
February 25, 2025

Primary Completion (Estimated)

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.
December 31, 2025

Study Completion (Estimated)

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.
December 31, 2025

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).
February 24, 2025

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.
February 24, 2025

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.
February 28, 2025

Study Record Updates

Last Update Posted (Estimated)

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.
May 20, 2025

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.
May 19, 2025

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.
May 1, 2025

More Information

Terms related to this study

Keywords

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.
  • INFER Study 2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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