Iron Absorption and Variations of Iron Status, Hepcidin, Inflammation and Sex Hormones During the Menstrual Cycle (MBL_Abs)

November 21, 2023 updated by: Isabelle Herter-Aeberli

Iron Absorption and Variations of Iron Status Parameters, Hepcidin, Inflammatory Markers and Sex Hormones During the Menstrual Cycle

Iron supplementation is the first line of treatment of iron deficiency in most women, but we do not know when the best time is to supplement in the context of the menstrual cycle. With this study, we aim to measure and compare iron status, hepcidin, inflammatory markers, hormones estrogen and progesterone and changes in iron absorption at various points throughout the menstrual cycle, with a long-term view to determine best time for iron supplementation in relation to the menstrual cycle.

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.

Detailed Description

To date, very few studies have assessed iron absorption in relation to a woman's menstrual cycle. Although oral iron supplementation is considered the first line of treatment for iron deficiency in most women, there is no knowledge on the relationship between this intervention in the context of the menstrual cycle, and more specifically there is no knowledge on its potential implications for the most appropriate timing of iron supplementation. A better understanding of iron absorption during the menstrual cycle as well as kinetics of key parameters could allow the design of adapted and/or new interventions (e.g., timing of iron supplementation in relation to different phases of the menstrual cycle) to mitigate iron deficiency in menstruating women and can inform programs aimed at addressing iron deficiency

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.
10

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 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

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female, 18-30 years old
  • Weight <70 kg
  • Normal body mass index (18.5 - 25kg/m2)
  • Regular menstrual cycle (self-reported cycle length between 28 and 35 days in the past 6 months)
  • Depleted iron stores (serum ferritin ≤ 30 µg/L)
  • Signed informed consent
  • Able to read and understand English

Exclusion Criteria:

  • Use of hormonal contraceptives within a 3-month recall period
  • Anemia (hemoglobin < 117 g/L)
  • Any known major metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer, or cardiovascular diseases (according to the participants own statement)
  • Women with severe menstrual cramps that would prevent them from attending study meetings during menstruation (judged by the women)
  • Consumption of iron-containing supplements within 1 month prior to the start of study
  • Known difficulties with blood sampling
  • Pregnancy (serum human chorionic gonadotropin (hCG) < 5 mIU/mL)
  • Current smoking (>1 cigarette per week over a 1-month recall period)
  • Women who are planning to get pregnant within the study period, as this would affect iron metabolism and subsequent study measurements.
  • Inability to follow the study protocol

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

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: Experimental 54Fe
Participants will receive 54Fe at two time points throughout their menstrual cycle.
Other: Test meal labelled with 54Fe
Each participant will receive 2 test meals containing 4mg each of isotopic tracer 54Fe
Experimental: Experimental 57Fe
Participants will receive 57Fe at two time points throughout their menstrual cycle.
Other: Test meal labelled with 57Fe
Each participant will receive 2 test meals containing 4mg each of isotopic tracer 57Fe
Experimental: Experimental 58Fe
Participants will receive 58Fe at two time points throughout their menstrual cycle.
Other: Test meal labelled with 58Fe
Each participant will receive 2 test meals containing 4mg each of isotopic tracer 58Fe

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 (%)
Time Frame: Day 2, 18, 22, 26 and 40
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the labelled test meals.
Day 2, 18, 22, 26 and 40

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
Hemoglobin concentration (g/L)
Time Frame: Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28 and 40
Haemoglobin will be measured to determine presence of anaemia
Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28 and 40
Serum ferritin (microg/L)
Time Frame: Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Iron status parameter
Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum transferrin receptor (mg/L)
Time Frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Iron status parameter
Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum iron (microg/mL)
Time Frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Iron status parameter
Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum hepcidin (nmol/L)
Time Frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Hepcidin, a major regulator of iron absorption and influenced by inflammation, will be measured
Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Alpha-1-acid glycoprotein (g/L)
Time Frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Chronic inflammation parameter
Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
C-reactive protein (mg/L)
Time Frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Acute inflammation parameter
Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum estradiol (pg/mL)
Time Frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Hormonal parameter
Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum progesterone (ng/mL)
Time Frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Hormonal parameter
Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Total iron binding capacity (microg/mL)
Time Frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Total iron binding capacity will be measured to determine the presence of iron deficiency
Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Menstrual blood volume loss/cycle
Time Frame: Menstruation
Semi-quantitative assessment to measure menstrual blood loss per cycle
Menstruation

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.
Isabelle Herter-Aeberli

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.
Kamuzu University of Health Sciences
Wageningen University and Research
Sight and Life Foundation

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.
November 5, 2022

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.
January 6, 2023

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.
May 15, 2023

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).
October 6, 2022

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.
October 11, 2022

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.
October 14, 2022

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.
November 22, 2023

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.
November 21, 2023

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.
November 1, 2023

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.
  • MBL_Abs
  • IZSTZ0_208432/1 (Other Grant/Funding Number: Swiss National Science Foundation)

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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