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HEPMEN: Study of Serum Hepcidin Rate Variations During Menstrual Cycle

Sponsor
Rennes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01764412
Collaborator
(none)
147
Enrollment
4
Locations
23.1
Duration (Months)
36.8
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    147 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Study of Serum Hepcidin Rate Variations During Menstrual Cycle
    Study Start Date :
    Mar 1, 2013
    Actual Primary Completion Date :
    Mar 1, 2014
    Actual Study Completion Date :
    Feb 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Healthy women

    Non interventional

    Outcome Measures

    Primary Outcome Measures

    1. Serum hepcidin rates variations during the menstrual cycle [During the menstrual cycle (see description)]

      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

    Secondary Outcome Measures

    1. Seric iron [During the menstrual cycle (see description)]

      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

    2. transferrin saturation [During the menstrual cycle (see description)]

      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

    3. serum transferrin [During the menstrual cycle (see description)]

      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

    4. serum ferritin [During the menstrual cycle (see description)]

      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

    5. hepcidin / ferritin rate [During the menstrual cycle (see description)]

      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

    6. hepcidin / transferrin saturation rate [During the menstrual cycle (see description)]

      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

    7. hepcidin / serum iron rate [During the menstrual cycle (see description)]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Rennes Rennes Bretagne France 35000
    2 Chu Brest Brest France 29200
    3 CHU Nantes Nantes France 44000
    4 Chru Tours Tours France 37000

    Sponsors and Collaborators

    • Rennes University Hospital

    Investigators

    • Principal Investigator: Fabrice lainé, MD, CHU de Rennes - CIC INSERM 0203

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rennes University Hospital
    ClinicalTrials.gov Identifier:
    NCT01764412
    Other Study ID Numbers:
    • 2012-A01122-41
    First Posted:
    Jan 9, 2013
    Last Update Posted:
    Mar 30, 2015
    Last Verified:
    Aug 1, 2014
    Keywords provided by Rennes University Hospital
    Healthy women
    Menstrual cycle
    Hepcidin
    Seric iron

    Study Results

    No Results Posted as of Mar 30, 2015