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Completed

NCT Number: NCT05580783

Iron Absorption and Variations of Iron Status, Hepcidin, Inflammation and Sex Hormones During the Menstrual Cycle

Iron supplementation is the first line of treatment of iron deficiency in most women, but we do not know when the best time is to supplement in the context of the menstrual cycle. With this study, we aim to measure and compare iron status, hepcidin, inflammatory markers, hormones estrogen and progesterone and changes in iron absorption at various points throughout the menstrual cycle, with a long-term view to determine best time for iron supplementation in relation to the menstrual cycle.

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Key information

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ETH Zurich

Zurich, 8092, Switzerland

About this study

To date, very few studies have assessed iron absorption in relation to a woman's menstrual cycle. Although oral iron supplementation is considered the first line of treatment for iron deficiency in most women, there is no knowledge on the relationship between this intervention in the context of the menstrual cycle, and more specifically there is no knowledge on its potential implications for the most appropriate timing of iron supplementation. A better understanding of iron absorption during the menstrual cycle as well as kinetics of key parameters could allow the design of adapted and/or new interventions (e.g., timing of iron supplementation in relation to different phases of the menstrual cycle) to mitigate iron deficiency in menstruating women and can inform programs aimed at addressing iron deficiency

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female, 18-30 years old
  • 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)
  • Depleted iron stores (serum ferritin ≤ 30 µg/L)
  • 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 that would prevent them from attending study meetings during menstruation (judged by the women)
  • 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 within the study period, as this would affect iron metabolism and subsequent study measurements.
  • Inability to follow the study protocol

Treatment and study plan

Test meal labelled with 54Fe

Other

Each participant will receive 2 test meals containing 4mg each of isotopic tracer 54Fe

Test meal labelled with 57Fe

Other

Each participant will receive 2 test meals containing 4mg each of isotopic tracer 57Fe

Test meal labelled with 58Fe

Other

Each participant will receive 2 test meals containing 4mg each of isotopic tracer 58Fe

Primary outcomes

  1. Fractional iron absorption (%)

    Time frame: Day 2, 18, 22, 26 and 40

    Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the labelled test meals.

Secondary outcomes

  1. Hemoglobin concentration (g/L)

    Time frame: Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28 and 40

    Haemoglobin will be measured to determine presence of anaemia

  2. Serum ferritin (microg/L)

    Time frame: Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28

    Iron status parameter

  3. Serum transferrin receptor (mg/L)

    Time frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28

    Iron status parameter

  4. Serum iron (microg/mL)

    Time frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28

    Iron status parameter

  5. Serum hepcidin (nmol/L)

    Time frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28

    Hepcidin, a major regulator of iron absorption and influenced by inflammation, will be measured

  6. Alpha-1-acid glycoprotein (g/L)

    Time frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28

    Chronic inflammation parameter

  7. C-reactive protein (mg/L)

    Time frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28

    Acute inflammation parameter

  8. Serum estradiol (pg/mL)

    Time frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28

    Hormonal parameter

  9. Serum progesterone (ng/mL)

    Time frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28

    Hormonal parameter

  10. Total iron binding capacity (microg/mL)

    Time frame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28

    Total iron binding capacity will be measured to determine the presence of iron deficiency

  11. Menstrual blood volume loss/cycle

    Time frame: Menstruation

    Semi-quantitative assessment to measure menstrual blood loss per cycle

Sponsors and collaborators

Lead sponsor

Isabelle Herter-Aeberli

Other

Collaborators

  • Kamuzu University of Health Sciences
  • Sight and Life Foundation
  • Wageningen University and Research

Registry information

Official study title

Iron Absorption and Variations of Iron Status Parameters, Hepcidin, Inflammatory Markers and Sex Hormones During the Menstrual Cycle

Acronym: MBL_Abs

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2022
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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