Clinical Trials Directory

Trials / Completed

CompletedNCT05788172

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
Phase
Study type
Observational
Enrollment
10 (actual)
Sponsor
Isabelle Herter-Aeberli · Academic / Other
Sex
Female
Age
18 Years – 30 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERIron isotope dilutionMenstrual blood loss will be determined using the iron isotope dilution technique and compared to the amount determined via the alkaline hematin method.
OTHERAlkaline hematin methodMenstrual blood loss will be determined using the alkaline hematin method and compared to the amount determined via the iron isotope dilution technique.

Timeline

Start date
2023-03-01
Primary completion
2023-06-29
Completion
2023-08-30
First posted
2023-03-28
Last updated
2023-11-22

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT05788172. Inclusion in this directory is not an endorsement.