Study of Serum Hepcidin Rate Variations During Menstrual Cycle

Study Overview
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Brief Summary
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Hepcidin is the major hormone regulating Iron Metabolism. In a normal organism decrease iron stock causes a decrease in hepcidin synthesis thus promoting intestinal absorption of iron. The interpretation of hepcidin dosage results requires to know the physiological variations of this hormone. This study investigate whether there are significant variations in the values of serum hepcidin rates during the menstrual cycle in order to make recommendations on the practical dosage determination of hepcidin in premenopausal women.

Detailed Description
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Hepcidin is the major hormone regulating Iron Metabolism. Synthesized primarily by hepatocytes, it interacts with the cellular iron exporter ferroportin, causing its internalization and preventing the release of iron from enterocytes and macrophages. In a normal organism decrease iron stock causes a decrease in hepcidin synthesis thus promoting intestinal absorption of iron. Since valid methods for the determination of hepcidin serum rate are available, this dosage is increasingly used to diagnosis iron metabolism pathologies, in particular iron overload. The interpretation of hepcidin dosage results requires to know physiological variations of this hormone. Several works have shown that hepcidin varies according to a circadian cycle, that its values differ by sex and, in women, by age. As far as the investigators know, no study has focused on possible variations in serum hepcidin rates values during menstrual cycle in women. Yet this question seems relevant since it has been shown that during the menstrual cycle blood loss can cause significant iron and hemoglobin variations, which can significantly modulate the synthesis of hepcidin. This study investigate whether there are significant variations in the values of serum hepcidin rates during the menstrual cycle in order to make recommendations on the practical dosage determination of hepcidin in premenopausal women.

Official Title
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Study of Serum Hepcidin Rate Variations During Menstrual Cycle

Conditions
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Healthy Women

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Woman aged over 18 and under 45 years, Having given free and informed written consent, Having regular cycles (defined by a constant interval between periods of 28 to 30 days), Having periods for a duration of 4 + / - 1 days Not using contraception or using oral oestroprogestative contraception. Exclusion Criteria: Contraceptive IUD Metrorrhagia Pregnancy, BMI under 18 kg / m² and above 30 kg / m², Presence of at least one of the following abnormalities in serum iron balance : Hemoglobin <11.5 g / dl, transferrin saturation under 15% or greater than 50%, serum ferritin under 15μg / l or greater than 150 µg / l Active smoking or quit within the last 6 months Drinking more than 20 g of alcohol per day , Iron supplementation or blood transfusion within 12 months before inclusion Blood donation within 3 months before inclusion, Stay in altitude> 1500 m in the previous month before inclusion Chronic inflammatory disease, Incapable people over 18 (judicial protection, guardianship) and persons deprived of their liberty.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy women<br>Non interventional | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum hepcidin rates variations during the menstrual cycle | Time frame : depending on the calendar day of D1 as the following calendars (D1: first day after periods beginning) D1 occurring on Monday : D1, D3, D4, D8, D15, D26 D1 occurring on Tuesday : D1, D2, D4, D7, D11, D28 D1 occurring on Wednesday : D1, D2, D6, D7, D13, D28 D1 occurring on Thursday : D1, D2, D5, D6, D13, D28 D1 occurring on Friday : D1, D4, D5, D6, D11, D27 D1 occurring on Saturday : D3, D4, D5, D12, D20, D27 D1 occurring on Sunday : D3, D4, D5, D12, D19, D26 | During the menstrual cycle (see description) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seric iron | Time frame : depending on the calendar day of D1 as the following calendars (D1: first day after periods beginning) D1 occurring on Monday : D1, D3, D4, D8, D15, D26 D1 occurring on Tuesday : D1, D2, D4, D7, D11, D28 D1 occurring on Wednesday : D1, D2, D6, D7, D13, D28 D1 occurring on Thursday : D1, D2, D5, D6, D13, D28 D1 occurring on Friday : D1, D4, D5, D6, D11, D27 D1 occurring on Saturday : D3, D4, D5, D12, D20, D27 D1 occurring on Sunday : D3, D4, D5, D12, D19, D26 | During the menstrual cycle (see description) | 
| transferrin saturation | Time frame : depending on the calendar day of D1 as the following calendars (D1: first day after periods beginning) D1 occurring on Monday : D1, D3, D4, D8, D15, D26 D1 occurring on Tuesday : D1, D2, D4, D7, D11, D28 D1 occurring on Wednesday : D1, D2, D6, D7, D13, D28 D1 occurring on Thursday : D1, D2, D5, D6, D13, D28 D1 occurring on Friday : D1, D4, D5, D6, D11, D27 D1 occurring on Saturday : D3, D4, D5, D12, D20, D27 D1 occurring on Sunday : D3, D4, D5, D12, D19, D26 | During the menstrual cycle (see description) | 
| serum transferrin | Time frame : depending on the calendar day of D1 as the following calendars (D1: first day after periods beginning) D1 occurring on Monday : D1, D3, D4, D8, D15, D26 D1 occurring on Tuesday : D1, D2, D4, D7, D11, D28 D1 occurring on Wednesday : D1, D2, D6, D7, D13, D28 D1 occurring on Thursday : D1, D2, D5, D6, D13, D28 D1 occurring on Friday : D1, D4, D5, D6, D11, D27 D1 occurring on Saturday : D3, D4, D5, D12, D20, D27 D1 occurring on Sunday : D3, D4, D5, D12, D19, D26 | During the menstrual cycle (see description) | 
| serum ferritin | Time frame : depending on the calendar day of D1 as the following calendars (D1: first day after periods beginning) D1 occurring on Monday : D1, D3, D4, D8, D15, D26 D1 occurring on Tuesday : D1, D2, D4, D7, D11, D28 D1 occurring on Wednesday : D1, D2, D6, D7, D13, D28 D1 occurring on Thursday : D1, D2, D5, D6, D13, D28 D1 occurring on Friday : D1, D4, D5, D6, D11, D27 D1 occurring on Saturday : D3, D4, D5, D12, D20, D27 D1 occurring on Sunday : D3, D4, D5, D12, D19, D26 | During the menstrual cycle (see description) | 
| hepcidin / ferritin rate | Time frame : depending on the calendar day of D1 as the following calendars (D1: first day after periods beginning) D1 occurring on Monday : D1, D3, D4, D8, D15, D26 D1 occurring on Tuesday : D1, D2, D4, D7, D11, D28 D1 occurring on Wednesday : D1, D2, D6, D7, D13, D28 D1 occurring on Thursday : D1, D2, D5, D6, D13, D28 D1 occurring on Friday : D1, D4, D5, D6, D11, D27 D1 occurring on Saturday : D3, D4, D5, D12, D20, D27 D1 occurring on Sunday : D3, D4, D5, D12, D19, D26 | During the menstrual cycle (see description) | 
| hepcidin / transferrin saturation rate | Time frame : depending on the calendar day of D1 as the following calendars (D1: first day after periods beginning) D1 occurring on Monday : D1, D3, D4, D8, D15, D26 D1 occurring on Tuesday : D1, D2, D4, D7, D11, D28 D1 occurring on Wednesday : D1, D2, D6, D7, D13, D28 D1 occurring on Thursday : D1, D2, D5, D6, D13, D28 D1 occurring on Friday : D1, D4, D5, D6, D11, D27 D1 occurring on Saturday : D3, D4, D5, D12, D20, D27 D1 occurring on Sunday : D3, D4, D5, D12, D19, D26 | During the menstrual cycle (see description) | 
| hepcidin / serum iron rate | Time frame : depending on the calendar day of D1 as the following calendars (D1: first day after periods beginning) D1 occurring on Monday : D1, D3, D4, D8, D15, D26 D1 occurring on Tuesday : D1, D2, D4, D7, D11, D28 D1 occurring on Wednesday : D1, D2, D6, D7, D13, D28 D1 occurring on Thursday : D1, D2, D5, D6, D13, D28 D1 occurring on Friday : D1, D4, D5, D6, D11, D27 D1 occurring on Saturday : D3, D4, D5, D12, D20, D27 D1 occurring on Sunday : D3, D4, D5, D12, D19, D26 | During the menstrual cycle (see description) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy women, Menstrual cycle, Hepcidin, Seric iron