Clinical trial NCT05788172: Measuring Menstrual Iron Loss Using the Iron Isotope Dilution Technique
Official title: Quantifying Menstrual Blood Loss: Validating the Methodology for Stable Iron Isotopes Dilution Against the Alkaline Hematin Method
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron-deficiency
Menorrhagia
Anemia
Keywords: anemia
menstruation
alkaline hematin
iron isotope dilution
blood loss
menorrhagia
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Wageningen University and Research
name: Sight and Life Foundation
name: Kamuzu University of Health Sciences
First posted: 2023-03-28
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female 18-30 year olds, who have already been labelled with stable iron isotopes.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

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
* 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
* Inability to follow the study protocol

Primary outcomes:
measure: Amount of menstrual blood lost (mL/cycle)
timeFrame: At the beginning of menstrual cycle 1 (cycle length between 28 and 35 days)
measure: Amount of menstrual blood lost (mL/cycle)
timeFrame: At the beginning of menstrual cycle 2 (cycle length between 28 and 35 days)
measure: Amount of menstrual blood lost (mL/cycle)
timeFrame: At the beginning of menstrual cycle 3 (cycle length between 28 and 35 days)
measure: Change in isotopic ratio per cycle
timeFrame: Screening, day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 and 85
Secondary outcomes:
measure: Hemoglobin concentration (g/L)
timeFrame: Screening, day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 and 85
measure: Serum ferritin (microg/L)
timeFrame: Day 1 and 85
measure: Serum transferrin receptor (mg/L)
timeFrame: Day 1 and 85
measure: Alpha-1-acid glycoprotein (g/L)
timeFrame: Day 1 and 85
measure: C-reactive protein (mg/L)
timeFrame: Day 1 and 85
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: ETH Zurich
Study officials:
affiliation: ETH
name: Isabelle Herter-Aeberli, PhD
role: PRINCIPAL_INVESTIGATOR
References: