Single Center Clinical Trial to Evaluate the Effect of Different Amounts of Iron Supplements on the Plasma Hepcidin Level in Non-anemic Iron-deficient Females
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Plasma hepcidin change
研究概览
简要总结
The study participants will take 3 different doses of iron supplements at 8 am, on 3 different days. By taking blood samples in the morning and afternoon, the investigators will determine the effects of the iron supplements on plasma hepcidin and compare them to baseline plasma hepcidin values.
详细描述
15 healthy young women with non-anemic iron deficiency will participate in the study. On 4 different days the investigators will take two blood samples (one in the morning at 8 am, before the iron intake and one in the afternoon at 4 pm) to determine the plasma hepcidin level. The intake of the iron supplements will be at least 48 hours apart from each other, to exclude any impacts of the previous iron intake to the next measurement.
The participants will take the iron supplement supervised at 8 am after overnight fasting.
All blood samples will be performed for analysis of CRP and hepcidin. The investigators will measure the CRP in the blood sample to exclude any impacts of inflammation to the hepcidin measurement and use a CRP ≤5mg/l as a cut-off. If the CRP is higher than 5mg/l the investigators will exclude the measurement from our analyses and repeat the measurement at another day.
The first two blood samples will be taken at 8 am and at 4 pm on the same day and after overnight fasting to find the baseline hepcidin, the other blood samples will be taken at 8 am before the iron intake and at 4 pm also on the same day and also after overnight fasting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Informed Consent as documented by signature
- •Female gender
- •Premenopausal
- •Age > 18 years
- •Regular menstrual cycle
- •BMI in normal range (18-25kg/m2)
- •Serum-ferritin ≤30ng/ml
- •No anemia
- •No intake of dietary supplements
排除标准
- •Intake of dietary supplements
- •Pregnancy
- •Hypermenorrhea (> 80ml blood loss, or more than 5 unties/tampons per day)
- •Serum-ferritin >30ng/ml
- •BMI <18 kg/m2 or >25 kg/m2
- •Chronic inflammatory disease
- •Hypersensitivity to iron supplements
结局指标
主要结局
Plasma hepcidin change
时间窗: The hepcidin measurement of all samples will be done after the last blood sample of the last participant is taken. Which is planed to be done up to 6 month from the first baseline visit.
The investigators will measure the plasma hepcidin level of the patients in the morning at 8am, (right before the intake of the iron-supplement) as well as in the afternoon at 4pm. The investigators will also measure the plasma hepcidin level on a baseline day (at the same times), when the patients don't take any iron supplement. By these measurements the investigators will report the change in the plasma hepcidin level after the intake of an iron-supplement.
次要结局
- Dose-response relationship between iron and hepcidin(The hepcidin measurement of all samples will be done after the last blood sample of the last participant is taken. Which is planed to be done up to 6 month from the first baseline visit.)
研究者
Pierre-Alexandre Krayenbuehl
Research associate at the Clinic for Endocrinology
University of Zurich