Study of Serum Hepcidin Rate Variations During Menstrual Cycle

NCT01764412 | Completed

• 1 other identifier: 2012-A01122-41
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 4

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.

Conditions

Healthy Women

Keywords

Healthy women; Menstrual cycle; Hepcidin; Seric iron

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (7)

• Seric iron

  During the menstrual cycle (see description)

• transferrin saturation

  During the menstrual cycle (see description)

• serum transferrin

  During the menstrual cycle (see description)

• serum ferritin

  During the menstrual cycle (see description)

• hepcidin / ferritin rate

  During the menstrual cycle (see description)

Study Arms (1)

Healthy women

Non interventional

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy women

You may qualify if:

• 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.

You may not qualify if:

• 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 ,
• Chronic inflammatory disease,
• Incapable people over 18 (judicial protection, guardianship) and persons deprived of their liberty.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (4)

CHU Rennes

Rennes, Brittany Region, 35000, France

Location

Chu Brest

Brest, 29200, France

Location

CHU Nantes

Nantes, 44000, France

Location

Chru Tours

Tours, 37000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Hepcidin Serum iron Transfferin saturation Serum transfferin Serum ferritin

Study Officials

• Fabrice lainé, MD

  CHU de Rennes - CIC INSERM 0203

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 9, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: February 1, 2015
• Last Updated: March 30, 2015

Record last verified: 2014-08

Locations

FR (4)