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

Not Applicable

Completed

• Conditions: Iron-deficiency
• Interventions: Other: Test meal labelled with 57Fe; Other: Test meal labelled with 58Fe; Other: Test meal labelled with 54Fe

• Registration Number: NCT05580783
• Lead Sponsor: Isabelle Herter-Aeberli

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-11
• Study First Posted: 2022-10-14
• Study Start: 2022-11-05
• Primary Completion: 2023-01-06
• Study Completion: 2023-05-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental 57Fe	Test meal labelled with 57Fe	Participants will receive 57Fe at two time points throughout their menstrual cycle.
Experimental 58Fe	Test meal labelled with 58Fe	Participants will receive 58Fe at two time points throughout their menstrual cycle.
Experimental 54Fe	Test meal labelled with 54Fe	Participants will receive 54Fe at two time points throughout their menstrual cycle.

Primary Outcome Measures

Name	Time	Method
Fractional iron absorption (%)	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 Outcome Measures

Name	Time	Method
Serum ferritin (microg/L)	Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28	Iron status parameter
Serum hepcidin (nmol/L)	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
C-reactive protein (mg/L)	Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28	Acute inflammation parameter
Hemoglobin concentration (g/L)	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
Serum transferrin receptor (mg/L)	Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28	Iron status parameter
Alpha-1-acid glycoprotein (g/L)	Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28	Chronic inflammation parameter
Serum iron (microg/mL)	Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28	Iron status parameter
Serum estradiol (pg/mL)	Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28	Hormonal parameter
Serum progesterone (ng/mL)	Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28	Hormonal parameter
Total iron binding capacity (microg/mL)	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
Menstrual blood volume loss/cycle	Menstruation	Semi-quantitative assessment to measure menstrual blood loss per cycle

Trial Locations

Locations (1)

ETH Zurich; 🇨🇭 Zurich, Switzerland