Clinical trial NCT01764412: Study of Serum Hepcidin Rate Variations During Menstrual Cycle
Official title: Study of Serum Hepcidin Rate Variations During Menstrual Cycle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Women
Keywords: Healthy women
Menstrual cycle
Hepcidin
Seric iron
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 147
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy women

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.

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 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.

Primary outcomes:
measure: Serum hepcidin rates variations during the menstrual cycle
timeFrame: During the menstrual cycle (see description)
Secondary outcomes:
measure: Seric iron
timeFrame: During the menstrual cycle (see description)
measure: transferrin saturation
timeFrame: During the menstrual cycle (see description)
measure: serum transferrin
timeFrame: During the menstrual cycle (see description)
measure: serum ferritin
timeFrame: During the menstrual cycle (see description)
measure: hepcidin / ferritin rate
timeFrame: During the menstrual cycle (see description)
measure: hepcidin / transferrin saturation rate
timeFrame: During the menstrual cycle (see description)
measure: hepcidin / serum iron rate
timeFrame: During the menstrual cycle (see description)
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
state: Bretagne
city: Brest
country: France
facility: Chu Brest
city: Nantes
country: France
facility: CHU Nantes
city: Tours
country: France
facility: Chru Tours
Study officials:
affiliation: CHU de Rennes - CIC INSERM 0203
name: Fabrice lainé, MD
role: PRINCIPAL_INVESTIGATOR
References: