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临床试验/NCT05788172
NCT05788172已完成不适用

Quantifying Menstrual Blood Loss: Validating the Methodology for Stable Iron Isotopes Dilution Against the Alkaline Hematin Method

Isabelle Herter-Aeberli1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年3月1日最近更新:
适应症

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
Change in isotopic ratio per cycle

研究概览

简要总结

It is very difficult to quantify menstrual blood loss, the reference method is a tedious one. This is a problem, as it is not conducive to objectively measuring menstrual blood loss and understanding the contribution of menstrual iron loss to iron deficiency anemia. With this study, the investigators aim to investigate iron loss during the menstrual cycle and aim to validate a much simpler technique.

详细描述

Anemia reduction efforts have largely focused on increasing iron intakes such as improving diet quality, food fortification with iron, iron supplementation, biofortification. There is little information on the contribution of menstrual iron loss to iron deficiency anemia.

Indeed, the accurate measurement of menstrual blood loss volume and iron loss is difficult. Self-perception of heavy menstrual blood loss poorly predicts actual blood loss, and the objective measurement of menstrual blood loss remains a tedious method. Various methods have been used to objectively measure menstrual blood loss volume including radioisotopes, but these methods are invasive. The investigators aim to validate a much simpler technique, namely the stable iron isotope dilution methodology. This is a promising new method for quantifying long-term body iron balance, absorption, and loss which has not been applied previously to measure menstrual iron losses. Validating this new method against the alkaline hematin reference method would be an important step to encourage menstrual blood loss measurements and shed light on the contribution of menstrual blood loss to iron deficiency and iron deficiency anemia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female, 18-30 years old
  • Already labelled with stable iron isotopes at least 12 months prior to study start
  • 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)
  • 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
  • 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
  • Inability to follow the study protocol

结局指标

主要结局

Change in isotopic ratio per cycle

时间窗: Screening, day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 and 85

The change in iron losses between the time of menstruation and the remaining duration of the cycle will be measured based on the dilution of the stable iron isotopes in the blood

Amount of menstrual blood lost (mL/cycle)

时间窗: At the beginning of menstrual cycle 3 (cycle length between 28 and 35 days)

The amount of menstrual blood lost will be determined using the alkaline hematin reference method. All sanitary material is collected during menstruation in each cycle and the amount of blood lost is measured directly in this material. For each cycle the total amount of blood lost during this cycle is determined (there will be one value only during each cycle).

次要结局

  • Hemoglobin concentration (g/L)(Screening, day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 and 85)
  • Serum transferrin receptor (mg/L)(Day 1 and 85)
  • C-reactive protein (mg/L)(Day 1 and 85)
  • Serum ferritin (microg/L)(Day 1 and 85)
  • Alpha-1-acid glycoprotein (g/L)(Day 1 and 85)

研究者

发起方
Isabelle Herter-Aeberli
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Isabelle Herter-Aeberli

Principal Investigator

Swiss Federal Institute of Technology

研究点 (1)

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