Measuring Menstrual Iron Loss Using the Iron Isotope Dilution Technique

NCT05788172 | Completed

• 1 other identifier: MBL_Loss
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron-deficiency; Menorrhagia; Anemia

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (5)

• Hemoglobin concentration (g/L)

  Screening, day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 and 85

• Serum ferritin (microg/L)

  Day 1 and 85

• Serum transferrin receptor (mg/L)

  Day 1 and 85

• Alpha-1-acid glycoprotein (g/L)

  Day 1 and 85

• C-reactive protein (mg/L)

  Day 1 and 85

Study Arms (1)

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; Other: Alkaline hematin method

Interventions

Iron isotope dilution OTHER

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

Participants

Alkaline hematin method OTHER

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

Participants

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Female 18-30 year olds, who have already been labelled with stable iron isotopes.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Isabelle Herter-Aeberli: lead
• Wageningen University and Research: collaborator
• Sight and Life Foundation: collaborator
• Kamuzu University of Health Sciences: collaborator

Study Sites (1)

ETH Zurich

Zurich, 8092, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected for the measurement of hemoglobin, iron status and iron isotope dilution, as well as menstrual iron loss.

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Menorrhagia; Anemia; Hemorrhage

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• Isabelle Herter-Aeberli, PhD

  ETH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: March 28, 2023
• Study Start: March 1, 2023
• Primary Completion: June 29, 2023
• Study Completion: August 30, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)