Study of Serum Hepcidin Rate Variations During Menstrual Cycle (HEPMEN)

This study is currently recruiting participants.
Verified January 2014 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01764412
First received: January 7, 2013
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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
Healthy Women

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Serum Hepcidin Rate Variations During Menstrual Cycle

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Serum hepcidin rates variations during the menstrual cycle [ Time Frame: During the menstrual cycle (see description) ] [ Designated as safety issue: No ]

    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:
  • Seric iron [ Time Frame: During the menstrual cycle (see description) ] [ Designated as safety issue: No ]

    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

  • transferrin saturation [ Time Frame: During the menstrual cycle (see description) ] [ Designated as safety issue: No ]

    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

  • serum transferrin [ Time Frame: During the menstrual cycle (see description) ] [ Designated as safety issue: No ]

    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

  • serum ferritin [ Time Frame: During the menstrual cycle (see description) ] [ Designated as safety issue: No ]

    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

  • hepcidin / ferritin rate [ Time Frame: During the menstrual cycle (see description) ] [ Designated as safety issue: No ]

    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

  • hepcidin / transferrin saturation rate [ Time Frame: During the menstrual cycle (see description) ] [ Designated as safety issue: No ]

    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

  • hepcidin / serum iron rate [ Time Frame: During the menstrual cycle (see description) ] [ Designated as safety issue: No ]

    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


Biospecimen Retention:   Samples Without DNA

Hepcidin Serum iron Transfferin saturation Serum transfferin Serum ferritin


Estimated Enrollment: 90
Study Start Date: March 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy women
Non interventional

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy women

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764412

Contacts
Contact: Fabrice Lainé, MD 2 99 28 92 01 ext +33 fabrice.laine@chu-rennes.fr

Locations
France
CHU Rennes Recruiting
Rennes, Bretagne, France, 35000
Contact: Fabrice Lainé, MD    299289201 ext +33    fabrice.laine@chu-rennes.fr   
Principal Investigator: Fabrice Lainé, MD         
Chu Brest Not yet recruiting
Brest, France, 29200
Contact: Karine Lacut, MDPhD    2 98 34 50 00 ext +33    cic_centre_ressources_methodologique@chu-brest.fr   
Principal Investigator: Karine Lacut, MDPhD         
CHU Nantes Not yet recruiting
Nantes, France, 44000
Contact: Sylvie Sacher-Huvelin, MD    2.40.08.31.52 ext +33      
Principal Investigator: Sylvie Sacher-Huvelin, MD         
Chru Tours Not yet recruiting
Tours, France, 37000
Contact: Valérie Gissot, MD    2 34 37 96 53 ext +33    valerie.gissot@univ-tours.fr   
Principal Investigator: Valérie Gissot, MD         
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Fabrice lainé, MD CHU de Rennes - CIC INSERM 0203
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01764412     History of Changes
Other Study ID Numbers: 2012-A01122-41
Study First Received: January 7, 2013
Last Updated: January 27, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Rennes University Hospital:
Healthy women
Menstrual cycle
Hepcidin
Seric iron

Additional relevant MeSH terms:
Hepcidin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014