Healthy WomenHEPMENNCT01764412
Study of Serum Hepcidin Rate Variations During Menstrual Cycle
An observational study of Healthy Women, run by Rennes University Hospital at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Women
- How many people
- 147 participants
- Where
- 4 sitesFrance
- Study dates
- Mar 2013to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy women
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Chu Brest
Brest, 29200
CHU Nantes
Nantes, 44000
CHU Rennes
Rennes, Brittany Region, 35000
Chru Tours
Tours, 37000
About this study
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.
Read the 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.
- Conditions
- Healthy Women
- Keywords
- Healthy women, Menstrual cycle, Hepcidin, Seric iron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy women | Non interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the menstrual cycle (see description)
Secondary outcomes (7)
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
Measured: During the menstrual cycle (see description)
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
Measured: During the menstrual cycle (see description)
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
Measured: During the menstrual cycle (see description)
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
Measured: During the menstrual cycle (see description)
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
Measured: During the menstrual cycle (see description)
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
Measured: During the menstrual cycle (see description)
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
Measured: During the menstrual cycle (see description)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy WomenStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice lainé, MD, Principal investigator, CHU de Rennes - CIC INSERM 0203
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764412
- Sponsor's protocol ID
- 2012-A01122-41
- Acronym
- HEPMEN
- Status last verified
- Aug 2014
- First submitted
- 7 Jan 2013
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Serum Hepcidin Rate Variations During Menstrual Cycle
- ClinicalTrials.gov ID
- NCT01764412
- Acronym / sponsor ID
- HEPMEN / 2012-A01122-41
- Conditions
- Healthy Women
- Keywords
- Healthy women, Menstrual cycle, Hepcidin, Seric iron
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy women | – | –Non interventional |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
Seric iron
Time frame: During the menstrual cycle (see description)
transferrin saturation
Time frame: During the menstrual cycle (see description)
serum transferrin
Time frame: During the menstrual cycle (see description)
serum ferritin
Time frame: During the menstrual cycle (see description)
hepcidin / ferritin rate
Time frame: During the menstrual cycle (see description)
hepcidin / transferrin saturation rate
Time frame: During the menstrual cycle (see description)
hepcidin / serum iron rate
Time frame: During the menstrual cycle (see description)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice lainé, MD principal investigator
CHU de Rennes - CIC INSERM 0203
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Women, run by Rennes University Hospital at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum hepcidin rates variations during the menstrual cycle (time frame: During the menstrual cycle (see description)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2015.