ETH Zurich
Zurich, 8092, Switzerland
NCT Number: NCT05788172
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.
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Notify Me18 year–30 year
Female
Observational
Zurich, 8092, Switzerland
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Menstrual blood loss will be determined using the iron isotope dilution technique and compared to the amount determined via the 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: Day 1 and 85
Iron status parameter
Time frame: Day 1 and 85
Iron status parameter
Time frame: Day 1 and 85
Chronic inflammation parameter
Time frame: Day 1 and 85
Acute inflammation parameter
Isabelle Herter-Aeberli
Other
Quantifying Menstrual Blood Loss: Validating the Methodology for Stable Iron Isotopes Dilution Against the Alkaline Hematin Method
Acronym: MBL_Loss
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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