Iron-deficiencyMBL_LossNCT05788172
Measuring Menstrual Iron Loss Using the Iron Isotope Dilution Technique
An observational study of Iron-deficiency and Menorrhagia, run by Isabelle Herter-Aeberli at 1 site in Switzerland.
Trial summary
It is very difficult to quantify menstrual blood loss, the reference method is a tedious one. This is a problem, as it is not conducive to objectively measuring menstrual blood loss and understanding the contribution of menstrual iron loss to iron deficiency anemia. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency, Menorrhagia, Anemia
- What is being tested?
- Iron isotope dilution and Alkaline hematin method
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2023to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Female 18-30 year olds, who have already been labelled with stable iron isotopes.
Who may be able to join
- Female, 18-30 years old
- Already labelled with stable iron isotopes at least 12 months prior to study start
- 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)
- Signed informed consent
- Able to read and understand English
Who cannot join
- 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
- Consumption of iron-containing supplements within 1 month prior to the start of study
- Known difficulties with blood sampling
Show all 10Show fewer
- 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
- Inability to follow the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantifying Menstrual Blood Loss: Validating the Methodology for Stable Iron Isotopes Dilution Against the Alkaline Hematin Method
It is very difficult to quantify menstrual blood loss, the reference method is a tedious one. This is a problem, as it is not conducive to objectively measuring menstrual blood loss and understanding the contribution of menstrual iron loss to iron deficiency anemia. With this study, the investigators aim to investigate iron loss during the menstrual cycle and aim to validate a much simpler technique.
Read the detailed description
Anemia reduction efforts have largely focused on increasing iron intakes such as improving diet quality, food fortification with iron, iron supplementation, biofortification. There is little information on the contribution of menstrual iron loss to iron deficiency anemia.
Indeed, the accurate measurement of menstrual blood loss volume and iron loss is difficult. Self-perception of heavy menstrual blood loss poorly predicts actual blood loss, and the objective measurement of menstrual blood loss remains a tedious method. Various methods have been used to objectively measure menstrual blood loss volume including radioisotopes, but these methods are invasive. The investigators aim to validate a much simpler technique, namely the stable iron isotope dilution methodology. This is a promising new method for quantifying long-term body iron balance, absorption, and loss which has not been applied previously to measure menstrual iron losses. Validating this new method against the alkaline hematin reference method would be an important step to encourage menstrual blood loss measurements and shed light on the contribution of menstrual blood loss to iron deficiency and iron deficiency anemia.
- Conditions
- Iron-deficiency, Menorrhagia, Anemia
- Being tested
- Iron isotope dilution, Alkaline hematin method
- Keywords
- anemia, menstruation, alkaline hematin, iron isotope dilution, blood loss, menorrhagia
- Medical subject headings
- Anemia, Iron-Deficiency, Menorrhagia, Anemia, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron isotope dilutionOther
Menstrual blood loss will be determined using the iron isotope dilution technique and compared to the amount determined via the alkaline hematin method.
Alkaline hematin methodOther
Menstrual blood loss will be determined using the alkaline hematin method and compared to the amount determined via the iron isotope dilution technique.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Female 18-30 year olds, who have already been labelled with stable iron isotopes at least 12 months prior to study start. Receives: Other: Iron isotope dilution; Other: Alkaline hematin method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of menstrual blood lost (mL/cycle)
The amount of menstrual blood lost will be determined using the alkaline hematin reference method. All sanitary material is collected during menstruation in each cycle and the amount of blood lost is measured directly in this material. For each cycle the total amount of blood lost during this cycle is determined (there will be one value only during each cycle).
Measured: At the beginning of menstrual cycle 1 (cycle length between 28 and 35 days)
Amount of menstrual blood lost (mL/cycle)
The amount of menstrual blood lost will be determined using the alkaline hematin reference method. All sanitary material is collected during menstruation in each cycle and the amount of blood lost is measured directly in this material. For each cycle the total amount of blood lost during this cycle is determined (there will be one value only during each cycle).
Measured: At the beginning of menstrual cycle 2 (cycle length between 28 and 35 days)
Amount of menstrual blood lost (mL/cycle)
The amount of menstrual blood lost will be determined using the alkaline hematin reference method. All sanitary material is collected during menstruation in each cycle and the amount of blood lost is measured directly in this material. For each cycle the total amount of blood lost during this cycle is determined (there will be one value only during each cycle).
Measured: At the beginning of menstrual cycle 3 (cycle length between 28 and 35 days)
Change in isotopic ratio per cycle
The change in iron losses between the time of menstruation and the remaining duration of the cycle will be measured based on the dilution of the stable iron isotopes in the blood
Measured: Screening, day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 and 85
Secondary outcomes (5)
Hemoglobin concentration (g/L)
Hemoglobin will be measured to determine the presence of anemia and for the standardization of menstrual blood loss measurement
Measured: Screening, day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 and 85
Serum ferritin (microg/L)
Iron status parameter
Measured: Day 1 and 85
Serum transferrin receptor (mg/L)
Iron status parameter
Measured: Day 1 and 85
Alpha-1-acid glycoprotein (g/L)
Chronic inflammation parameter
Measured: Day 1 and 85
C-reactive protein (mg/L)
Acute inflammation parameter
Measured: Day 1 and 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 Mar 2023
- Primary completion29 Jun 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isabelle Herter-Aeberli
- Sponsor type
- University, hospital or other
- Collaborators
- Wageningen University and Research, Sight and Life Foundation, Kamuzu University of Health Sciences
- Responsible party
- Sponsor-investigator, Isabelle Herter-Aeberli, Swiss Federal Institute of Technology
- Investigators
- Isabelle Herter-Aeberli, PhD, Principal investigator, ETH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788172
- Sponsor's protocol ID
- MBL_Loss
- Acronym
- MBL_Loss
- Status last verified
- Nov 2023
- First submitted
- 30 Jan 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Menstrual Blood Loss: Validating the Methodology for Stable Iron Isotopes Dilution Against the Alkaline Hematin Method
- ClinicalTrials.gov ID
- NCT05788172
- Acronym / sponsor ID
- MBL_Loss / MBL_Loss
- Conditions
- Iron-deficiency, Menorrhagia, Anemia
- Keywords
- anemia, menstruation, alkaline hematin, iron isotope dilution, blood loss, menorrhagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Isabelle Herter-AeberliUniversity, hospital or other
- Collaborators
- Wageningen University and Research, Sight and Life Foundation, Kamuzu University of Health Sciences
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is very difficult to quantify menstrual blood loss, the reference method is a tedious one. This is a problem, as it is not conducive to objectively measuring menstrual blood loss and understanding the contribution of menstrual iron loss to iron deficiency anemia. With this study, the investigators aim to investigate iron loss during the menstrual cycle and aim to validate a much simpler technique.
Detailed description
Anemia reduction efforts have largely focused on increasing iron intakes such as improving diet quality, food fortification with iron, iron supplementation, biofortification. There is little information on the contribution of menstrual iron loss to iron deficiency anemia.
Indeed, the accurate measurement of menstrual blood loss volume and iron loss is difficult. Self-perception of heavy menstrual blood loss poorly predicts actual blood loss, and the objective measurement of menstrual blood loss remains a tedious method. Various methods have been used to objectively measure menstrual blood loss volume including radioisotopes, but these methods are invasive. The investigators aim to validate a much simpler technique, namely the stable iron isotope dilution methodology. This is a promising new method for quantifying long-term body iron balance, absorption, and loss which has not been applied previously to measure menstrual iron losses. Validating this new method against the alkaline hematin reference method would be an important step to encourage menstrual blood loss measurements and shed light on the contribution of menstrual blood loss to iron deficiency and iron deficiency anemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: Iron isotope dilution, Other: Alkaline hematin methodFemale 18-30 year olds, who have already been labelled with stable iron isotopes at least 12 months prior to study start. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female 18-30 year olds, who have already been labelled with stable iron isotopes.
Key inclusion criteria (7 listed)
- Female, 18-30 years old
- Already labelled with stable iron isotopes at least 12 months prior to study start
- 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)
Key exclusion criteria (10 listed)
- 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
- Consumption of iron-containing supplements within 1 month prior to the start of study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron isotope dilutionMenstrual blood loss will be determined using the iron isotope dilution technique and compared to the amount determined via the alkaline hematin method. | Other | Participants |
| Alkaline hematin methodMenstrual blood loss will be determined using the alkaline hematin method and compared to the amount determined via the iron isotope dilution technique. | Other | Participants |
Primary outcome
Amount of menstrual blood lost (mL/cycle)
Time frame: At the beginning of menstrual cycle 1 (cycle length between 28 and 35 days)
The amount of menstrual blood lost will be determined using the alkaline hematin reference method. All sanitary material is collected during menstruation in each cycle and the amount of blood lost is measured directly in this material. For each cycle the total amount of blood lost during this cycle is determined (there will be one value only during each cycle).
Amount of menstrual blood lost (mL/cycle)
Time frame: At the beginning of menstrual cycle 2 (cycle length between 28 and 35 days)
The amount of menstrual blood lost will be determined using the alkaline hematin reference method. All sanitary material is collected during menstruation in each cycle and the amount of blood lost is measured directly in this material. For each cycle the total amount of blood lost during this cycle is determined (there will be one value only during each cycle).
Amount of menstrual blood lost (mL/cycle)
Time frame: At the beginning of menstrual cycle 3 (cycle length between 28 and 35 days)
The amount of menstrual blood lost will be determined using the alkaline hematin reference method. All sanitary material is collected during menstruation in each cycle and the amount of blood lost is measured directly in this material. For each cycle the total amount of blood lost during this cycle is determined (there will be one value only during each cycle).
Change in isotopic ratio per cycle
Time frame: Screening, day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 and 85
The change in iron losses between the time of menstruation and the remaining duration of the cycle will be measured based on the dilution of the stable iron isotopes in the blood
5 secondary outcomes
Hemoglobin concentration (g/L)
Time frame: Screening, day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 and 85
Serum ferritin (microg/L)
Time frame: Day 1 and 85
Serum transferrin receptor (mg/L)
Time frame: Day 1 and 85
Alpha-1-acid glycoprotein (g/L)
Time frame: Day 1 and 85
C-reactive protein (mg/L)
Time frame: Day 1 and 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Herter-Aeberli, PhD principal investigator
ETH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron-deficiency and Menorrhagia, run by Isabelle Herter-Aeberli at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of menstrual blood lost (mL/cycle) (time frame: At the beginning of menstrual cycle 1 (cycle length between 28 and 35 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.