MBL_Loss: Measuring Menstrual Iron Loss Using the Iron Isotope Dilution Technique

Sponsor

Isabelle Herter-Aeberli (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05788172

Collaborator

Wageningen University and Research (Other), Sight and Life Foundation (Other), Kamuzu University of Health Sciences (Other)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Iron-deficiency Menorrhagia Anemia	Other: Iron isotope dilution Other: Alkaline hematin method

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

Study Type:

Observational

Actual Enrollment :

10 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jun 15, 2023

Anticipated Study Completion Date :

Jul 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Participants 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 Menstrual blood loss will be determined using the iron isotope dilution technique and compared to the amount determined via the alkaline hematin method. Other: 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.

Arm

Intervention/Treatment

Participants

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

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

Other: 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.

Outcome Measures

Primary Outcome Measures

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).
Amount of menstrual blood lost (mL/cycle) [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) [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 [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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Female

Accepts 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