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

Iron Absorption and Variations of Iron Status Parameters, Hepcidin, Inflammatory Markers 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.

Study Overview

• Status: Completed
• Conditions: Iron-deficiency
• Intervention / Treatment: Other: Test meal labelled with 54Fe; Other: Test meal labelled with 57Fe; Other: Test meal labelled with 58Fe

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8092
    • ETH Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental 54Fe; Participants will receive 54Fe at two time points throughout their menstrual cycle.	Other: Test meal labelled with 54Fe; Each participant will receive 2 test meals containing 4mg each of isotopic tracer 54Fe
Experimental: Experimental 57Fe; Participants will receive 57Fe at two time points throughout their menstrual cycle.	Other: Test meal labelled with 57Fe; Each participant will receive 2 test meals containing 4mg each of isotopic tracer 57Fe
Experimental: Experimental 58Fe; Participants will receive 58Fe at two time points throughout their menstrual cycle.	Other: Test meal labelled with 58Fe; Each participant will receive 2 test meals containing 4mg each of isotopic tracer 58Fe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fractional iron absorption (%)	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.	Day 2, 18, 22, 26 and 40

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin concentration (g/L)	Haemoglobin will be measured to determine presence of anaemia	Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28 and 40
Serum ferritin (microg/L)	Iron status parameter	Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum transferrin receptor (mg/L)	Iron status parameter	Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum iron (microg/mL)	Iron status parameter	Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum hepcidin (nmol/L)	Hepcidin, a major regulator of iron absorption and influenced by inflammation, will be measured	Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Alpha-1-acid glycoprotein (g/L)	Chronic inflammation parameter	Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
C-reactive protein (mg/L)	Acute inflammation parameter	Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum estradiol (pg/mL)	Hormonal parameter	Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Serum progesterone (ng/mL)	Hormonal parameter	Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Total iron binding capacity (microg/mL)	Total iron binding capacity will be measured to determine the presence of iron deficiency	Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Menstrual blood volume loss/cycle	Semi-quantitative assessment to measure menstrual blood loss per cycle	Menstruation

Collaborators and Investigators

• Sponsor: Isabelle Herter-Aeberli
• Collaborators: Kamuzu University of Health Sciences; Wageningen University and Research; Sight and Life Foundation

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2022
• Primary Completion (Actual): January 6, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: October 6, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Micronutrients; Anemia; Iron; Hormones; Menstruation; Trace elements
• Additional Relevant MeSH Terms: Metabolic Diseases; Iron Metabolism Disorders; Iron Deficiencies
• Other Study ID Numbers: MBL_Abs; IZSTZ0_208432/1 (Other Grant/Funding Number: Swiss National Science Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No