Healthy Women Clinical Trial
— HEPMENOfficial title:
Study of Serum Hepcidin Rate Variations During Menstrual Cycle
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.
Status | Completed |
Enrollment | 147 |
Est. completion date | February 2015 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | Chu Brest | Brest | |
France | CHU Nantes | Nantes | |
France | CHU Rennes | Rennes | Bretagne |
France | Chru Tours | Tours |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No |
Secondary | 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) | No |
Secondary | 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) | No |
Secondary | 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) | No |
Secondary | 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) | No |
Secondary | 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) | No |
Secondary | 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) | No |
Secondary | 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) | No |
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