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

Iron-deficiency Clinical Trial

— MBL_Abs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05580783
• Other study ID #: MBL_Abs
• Secondary ID: IZSTZ0_208432/1
• Status: Completed
• Phase: N/A
• Start date: November 5, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: November 2023
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 15, 2023
• Est. primary completion date: January 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Iron-deficiency

Intervention

Other:
• Test meal labelled with 54Fe
Each participant will receive 2 test meals containing 4mg each of isotopic tracer 54Fe
• Test meal labelled with 57Fe
Each participant will receive 2 test meals containing 4mg each of isotopic tracer 57Fe
• Test meal labelled with 58Fe
Each participant will receive 2 test meals containing 4mg each of isotopic tracer 58Fe

Locations

Country	Name	City	State
Switzerland	ETH Zurich	Zurich

Sponsors (4)

Lead Sponsor	Collaborator
Isabelle Herter-Aeberli	Kamuzu University of Health Sciences, Sight and Life Foundation, Wageningen University and Research

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Serum ferritin (microg/L)	Iron status parameter	Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Secondary	Serum transferrin receptor (mg/L)	Iron status parameter	Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Secondary	Serum iron (microg/mL)	Iron status parameter	Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Secondary	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
Secondary	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
Secondary	C-reactive protein (mg/L)	Acute inflammation parameter	Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Secondary	Serum estradiol (pg/mL)	Hormonal parameter	Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Secondary	Serum progesterone (ng/mL)	Hormonal parameter	Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
Secondary	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
Secondary	Menstrual blood volume loss/cycle	Semi-quantitative assessment to measure menstrual blood loss per cycle	Menstruation