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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01764412
Other study ID # 2012-A01122-41
Secondary ID
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


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
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