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 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT02979132
Eligibility Criteria:
Inclusion Criteria:
* Have participated in a former absorption study in our lab,
* Signed written informed consent to participate in the new study,
* Serum ferritin \< 25 µg/L
Exclusion Criteria:
* Anaemia (Hb \< 117 g/L),
* Any metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement),
* Allergic or similar reactions against iron supplements,
* Known fructose intolerance, glucose-galactose malabsorption or saccharase-isomaltase deficiency,
* Known hypersensitivity to ponceau R4 and ponceau R4 aluminium salt (E124)
* Continuous/long-term use of medication during the whole study (except for contraceptives),
* Regular consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration (more than 3 consecutive days or more than 5 times within 14 days),
* Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 6 months,
* pregnancy or breast feeding,
* Intention to become pregnant during the course of the study,
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Enrollment of the investigator, his/her family members, employees and other dependent persons
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02979132
Study Brief:
Protocol Section:
NCT02979132