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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT04849832
Eligibility Criteria:
Inclusion Criteria:
* female aged between 18-45 y old;
* SF \<80 µg/L;
* BMI 18.5-24.9 kg/m2;
* weight \<70 kg;
* signed informed consent;
* able to communicate and comprehend English language.
Exclusion Criteria:
* anemia (Hb \<12 g/dL);
* Inflammation (CRP \> 5 mg/L);
* chronic digestive, renal and/or metabolic disease;
* chronic medications (except for oral contraceptives);
* use of vitamin, mineral and pre- and/or probiotic supplements in the previous 2 weeks before study initiation and during the course of the study;
* blood transfusion, blood donation or significant blood loss over the past 4 months;
* difficulties with blood sampling;
* antibiotic treatment in the 4 weeks before study initiation;
* pregnancy (tested in serum at screening) or intention to become pregnant;
* lactation up to 6 weeks before study initiation;
* earlier participation in a study using stable isotopes or participation in any clinical study within the last 30 days;
* unable to comply with study protocol (e.g. not available on certain study appointment days or difficulties with blood withdrawal);
* inability to understand the information sheet and the informed consent form due to cognitive or language reasons;
* smoking;
* unwilling to use an effective method of contraception.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04849832
Study Brief:
Protocol Section:
NCT04849832