Measuring Menstrual Iron Loss Using the Iron Isotope Dilution Technique

Anemia Clinical Trial

— MBL_Loss  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05788172
• Other study ID #: MBL_Loss
• Status: Completed
• Start date: March 1, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: November 2023
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. With this study, the investigators aim to investigate iron loss during the menstrual cycle and aim to validate a much simpler technique.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 30, 2023
• Est. primary completion date: June 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Iron-deficiency
• Menorrhagia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	ETH Zurich	Zurich

Sponsors (4)

Lead Sponsor	Collaborator
Isabelle Herter-Aeberli	Kamuzu University of Health Sciences, Sight and Life Foundation, Wageningen University and Research

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	At the beginning of menstrual cycle 1 (cycle length between 28 and 35 days)
Primary	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).	At the beginning of menstrual cycle 2 (cycle length between 28 and 35 days)
Primary	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).	At the beginning of menstrual cycle 3 (cycle length between 28 and 35 days)
Primary	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	Screening, day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 and 85
Secondary	Hemoglobin concentration (g/L)	Hemoglobin will be measured to determine the presence of anemia and for the standardization of menstrual blood loss measurement	Screening, day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 and 85
Secondary	Serum ferritin (microg/L)	Iron status parameter	Day 1 and 85
Secondary	Serum transferrin receptor (mg/L)	Iron status parameter	Day 1 and 85
Secondary	Alpha-1-acid glycoprotein (g/L)	Chronic inflammation parameter	Day 1 and 85
Secondary	C-reactive protein (mg/L)	Acute inflammation parameter	Day 1 and 85