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 @ 12:31 PM
Ignite Modification Date:
2025-12-24 @ 12:31 PM
NCT ID:
NCT02585661
Eligibility Criteria:
Inclusion Criteria:
* Women aged 18-40 years old,
* Healthy, based on the medical screening visit including a blood formula and biochemistry,
* Normal BMI for age (18.5-25.0),
* Weight less than 65 kg,
* Having obtained informed consent prior trial entry.
Exclusion Criteria:
* Anemia or polycythemia respectively evidenced,
* Significant blood losses over the past 6 months,
* Plasma ferritin out of 8-50 ug/L range.
* Any infectious and inflammatory disease in the past four weeks,
* Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease,
* Known food allergy,
* Pregnancy (anamnesis) and/or lactation,
* History of cancer within the past year,
* Significant weight loss during the last 3 months (5% and more),
* medication or supplement which may impact red cells count, Hb or Ht
* Fe supplementation or perfusion in the last three months,
* Smokers (\>5 cigarettes),
* Have a high alcohol consumption (more than 2 drinks/day),
* Consumption of illicit drugs anamnesis only,
* Subject having a hierarchical link with the Investigator or co-investigators,
* Subject who cannot be expected to comply with treatment or study procedure,
* participating or having participated in another clinical trial during the past month prior to the beginning of this study.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02585661
Study Brief:
Protocol Section:
NCT02585661