Clinical trial NCT05580783: Iron Absorption and Variations of Iron Status, Hepcidin, Inflammation and Sex Hormones During the Menstrual Cycle
Official title: Iron Absorption and Variations of Iron Status Parameters, Hepcidin, Inflammatory Markers and Sex Hormones During the Menstrual Cycle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency
Keywords: Anemia
Micronutrients
Iron
Trace elements
Menstruation
Hormones
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Wageningen University and Research
name: Sight and Life Foundation
name: Kamuzu University of Health Sciences
First posted: 2022-10-14
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

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

Primary outcomes:
measure: Fractional iron absorption (%)
timeFrame: Day 2, 18, 22, 26 and 40
Secondary outcomes:
measure: Hemoglobin concentration (g/L)
timeFrame: Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28 and 40
measure: Serum ferritin (microg/L)
timeFrame: Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
measure: Serum transferrin receptor (mg/L)
timeFrame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
measure: Serum iron (microg/mL)
timeFrame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
measure: Serum hepcidin (nmol/L)
timeFrame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
measure: Alpha-1-acid glycoprotein (g/L)
timeFrame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
measure: C-reactive protein (mg/L)
timeFrame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
measure: Serum estradiol (pg/mL)
timeFrame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
measure: Serum progesterone (ng/mL)
timeFrame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
measure: Total iron binding capacity (microg/mL)
timeFrame: Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28
measure: Menstrual blood volume loss/cycle
timeFrame: Menstruation
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: ETH Zurich
Study officials:
References: