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

NCT ID: NCT05580783

Last Updated: 2023-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-05
• Study Completion Date: 2023-05-15

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

Conditions

Iron-deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Experimental 54Fe

Participants will receive 54Fe at two time points throughout their menstrual cycle.

Group Type: EXPERIMENTAL

Test meal labelled with 54Fe

Intervention Type: OTHER

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

Experimental 57Fe

Participants will receive 57Fe at two time points throughout their menstrual cycle.

Group Type: EXPERIMENTAL

Test meal labelled with 57Fe

Intervention Type: OTHER

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

Experimental 58Fe

Participants will receive 58Fe at two time points throughout their menstrual cycle.

Group Type: EXPERIMENTAL

Test meal labelled with 58Fe

Intervention Type: OTHER

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

Interventions

Test meal labelled with 54Fe

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

Intervention Type: OTHER

Test meal labelled with 57Fe

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

Intervention Type: OTHER

Test meal labelled with 58Fe

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Wageningen University and Research

OTHER

Sponsor Role: collaborator

Sight and Life Foundation

UNKNOWN

Sponsor Role: collaborator

Kamuzu University of Health Sciences

OTHER

Sponsor Role: collaborator

Isabelle Herter-Aeberli

OTHER

Sponsor Role: lead

Responsible Party

Isabelle Herter-Aeberli

Senior Scientist

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

ETH Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

IZSTZ0_208432/1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MBL_Abs

Identifier Type: -

Identifier Source: org_study_id