Iron Absorption and Variations of Iron Status Parameters, Hepcidin, Inflammatory Markers and Sex Hormones During the Menstrual Cycle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Fractional iron absorption (%)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental 54Fe
Participants will receive 54Fe at two time points throughout their menstrual cycle.
干预措施: Test meal labelled with 54Fe (Other)
Experimental 57Fe
Participants will receive 57Fe at two time points throughout their menstrual cycle.
干预措施: Test meal labelled with 57Fe (Other)
Experimental 58Fe
Participants will receive 58Fe at two time points throughout their menstrual cycle.
干预措施: Test meal labelled with 58Fe (Other)
结局指标
主要结局
Fractional iron absorption (%)
时间窗: 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.
次要结局
- Serum ferritin (microg/L)(Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28)
- Serum hepcidin (nmol/L)(Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28)
- C-reactive protein (mg/L)(Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28)
- Hemoglobin concentration (g/L)(Screening, day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28 and 40)
- Serum transferrin receptor (mg/L)(Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28)
- Alpha-1-acid glycoprotein (g/L)(Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28)
- Serum iron (microg/mL)(Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28)
- Serum estradiol (pg/mL)(Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28)
- Serum progesterone (ng/mL)(Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28)
- Total iron binding capacity (microg/mL)(Day 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28)
- Menstrual blood volume loss/cycle(Menstruation)
研究者
Isabelle Herter-Aeberli
Senior Scientist
Swiss Federal Institute of Technology