Study of Serum Hepcidin Rate Variations During Menstrual Cycle

Healthy Women Clinical Trial

— HEPMEN  

Official title:

Study of Serum Hepcidin Rate Variations During Menstrual Cycle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764412
• Other study ID #: 2012-A01122-41
• Status: Completed
• Phase: N/A
• First received: January 7, 2013
• Last updated: March 27, 2015
• Start date: March 2013
• Est. completion date: February 2015

Study information

• Verified date: August 2014
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Women

Locations

Country	Name	City	State
France	Chu Brest	Brest
France	CHU Nantes	Nantes
France	CHU Rennes	Rennes	Bretagne
France	Chru Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

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