Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT02993835
Eligibility Criteria:
Inclusion Criteria:
1. Women aged 18-40 years old
2. Healthy, based on the medical screening visit including a blood formula
3. Normal BMI for age (18.5-25.0 kg/m2)
4. Weight less than 65 kg
5. Able to understand and to sign written informed consent prior to trial entry
6. Informed consent signed
Exclusion Criteria:
1. Anemia or polycythemia respectively evidenced by one of the following criteria from a standard blood formula: number of erythrocytes 4.0 - 5.8 1012/l or Hb 120-160 g/l or Ht 35-55%. Subjects outside of this range will be excluded.
2. Significant blood losses over the past 6 months (i.e. trauma, major surgery, blood donation and other causes to be appreciated by the investigator).
3. Serum ferritin above 80 µg/L range. As a result, hemochromatosis will be excluded.
4. Any therapy or medication taken for any infectious and inflammatory disease in the past two weeks.
5. Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease, as determined by the screening visit and by self-report from the subjects.
6. Diagnosed food allergy.
7. Pregnancy (tested in plasma at screening) and/or lactation.
8. History of cancer within the past year.
9. Significant weight loss during the last 3 months (10% and more)
10. Any medication or supplement which may impact erythrocytes, Hb or Ht (to the opinion of the investigator).
11. Iron supplementation therapy or perfusion in the last three months.
12. Smokers (\> 5 cigarettes per day).
13. Have a high alcohol consumption (more than 2 drinks/day).
14. Consumption of illicit drugs (anamnesis only).
15. Subject having a hierarchical link with the investigator or co-investigators.
16. Subject who cannot be expected to comply with treatment or study procedure.
17. Currently participating or having participated in another clinical trial during the past month prior to the beginning of this study.
18. Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02993835
Study Brief:
Protocol Section:
NCT02993835