Skip to content

Measuring Menstrual Iron Loss Using the Iron Isotope Dilution Technique

Quantifying Menstrual Blood Loss: Validating the Methodology for Stable Iron Isotopes Dilution Against the Alkaline Hematin Method

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05788172
Acronym
MBL_Loss
Enrollment
10
Registered
2023-03-28
Start date
2023-03-01
Completion date
2023-08-30
Last updated
2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Iron-deficiency, Menorrhagia

Keywords

anemia, menstruation, alkaline hematin, iron isotope dilution, blood loss, menorrhagia

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.

Interventions

OTHERIron isotope dilution

Menstrual blood loss will be determined using the iron isotope dilution technique and compared to the amount determined via the alkaline hematin method.

OTHERAlkaline 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.

Sponsors

Wageningen University and Research
CollaboratorOTHER
Sight and Life Foundation
CollaboratorUNKNOWN
Kamuzu University of Health Sciences
CollaboratorOTHER
Isabelle Herter-Aeberli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Amount of menstrual blood lost (mL/cycle)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).
Change in isotopic ratio per cycleScreening, day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 and 85The 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

Secondary

MeasureTime frameDescription
Serum transferrin receptor (mg/L)Day 1 and 85Iron status parameter
Hemoglobin concentration (g/L)Screening, day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 and 85Hemoglobin will be measured to determine the presence of anemia and for the standardization of menstrual blood loss measurement
C-reactive protein (mg/L)Day 1 and 85Acute inflammation parameter
Alpha-1-acid glycoprotein (g/L)Day 1 and 85Chronic inflammation parameter
Serum ferritin (microg/L)Day 1 and 85Iron status parameter

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026