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Completed

NCT Number: NCT01764412

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.

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Key information

Conditions

Healthy Women

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

CHU Rennes, Rennes, Brittany Region, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Serum hepcidin rates variations during the menstrual cycle

    Time frame: 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 outcomes

  1. Seric iron

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: HEPMEN

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jan 9, 2013
Registry last updated
Mar 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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