An observational study in Iron-deficiency, Menorrhagia and Anemia, sponsored by Isabelle Herter-Aeberli. Completed at 1 site in Switzerland. Open to female participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Isabelle Herter-Aeberli · Observational
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.
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.
600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.
This study's enrollment of 10 is below the median of 200 across 118 observational studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →Isabelle Herter-Aeberli is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Female 18-30 year olds, who have already been labelled with stable iron isotopes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Female 18-30 year olds, who have already been labelled with stable iron isotopes at least 12 months prior to study start.
Other: Iron isotope dilution · Other: Alkaline hematin method
Menstrual blood loss will be determined using the iron isotope dilution technique and compared to the amount determined via the alkaline hematin method.
Menstrual blood loss will be determined using the alkaline hematin method and compared to the amount determined via the iron isotope dilution technique.
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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: Screening, day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 and 85
Hemoglobin concentration (g/L)
Hemoglobin will be measured to determine the presence of anemia and for the standardization of menstrual blood loss measurement
Time frame: Screening, day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 and 85
Serum ferritin (microg/L)
Iron status parameter
Time frame: Day 1 and 85
Serum transferrin receptor (mg/L)
Iron status parameter
Time frame: Day 1 and 85
Alpha-1-acid glycoprotein (g/L)
Chronic inflammation parameter
Time frame: Day 1 and 85
C-reactive protein (mg/L)
Acute inflammation parameter
Time frame: Day 1 and 85
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2023 to primary completion in Jun 2023, 3 months.
Of 49 non-industry observational studies under Anemia, Iron-Deficiency, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 38. This study's 3 months is below that.
Counting every sponsor, half of 54 studies reached it within 26 months; a quarter within 11 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Isabelle Herter-Aeberli