Iron-deficiency
Conditions
Keywords
Anemia, Micronutrients, Iron, Trace elements, Menstruation, Hormones
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
Interventions
OTHERTest meal labelled with 54Fe
Each participant will receive 2 test meals containing 4mg each of isotopic tracer 54Fe
OTHERTest meal labelled with 57Fe
Each participant will receive 2 test meals containing 4mg each of isotopic tracer 57Fe
OTHERTest meal labelled with 58Fe
Each participant will receive 2 test meals containing 4mg each of isotopic tracer 58Fe
Sponsors
Wageningen University and Research
Sight and Life Foundation
Kamuzu University of Health Sciences
Isabelle Herter-Aeberli
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 transferrin receptor (mg/L) | Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28 | Iron status 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 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 |
| 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 |
| 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 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 |
| C-reactive protein (mg/L) | Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28 | Acute inflammation parameter |
Countries
Switzerland
Outcome results
None listed