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 @ 5:42 PM
Ignite Modification Date:
2025-12-24 @ 5:42 PM
NCT ID:
NCT03210168
Eligibility Criteria:
Inclusion Criteria:
* Moderate iron deficiency defined as transferrin saturation (TSAT) \<20% and serum ferritin \<50 ng/mL.
Exclusion Criteria:
* Female subjects who are pregnant, plan to become pregnant, or not willing to use an acceptable form of contraception (tubal ligation or otherwise be incapable of pregnancy, hormonal contraceptives, spermicide plus barrier, or intrauterine device).
* Female subjects who are breastfeeding or plan to breastfeed after enrolling in the study.
* Hemochromatosis or other iron storage disorders.
* Hemoglobin below 8 g/dL.
* Previous gastric bypass, sleeve gastrectomy, or gastric band surgery.
* Currently on iron supplements and/or multivitamins containing iron (subjects may be pre-screened four weeks prior to the screening visit in order to stop/washout or switch to vitamins not containing iron).
* Currently on monoamine oxidase inhibitors (MAOIs) or Demerol.
* Current diagnosis of asthma and is actively using anti-asthmatic therapy.
* Smoking within two weeks of screening, current smoking, or anticipated smoking after enrolling in the study.
* Active malignancy within one year of screening.
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than two times the upper limit of normal.
* Known positive Hepatitis B, Hepatitis C, or HIV-1/HIV-2.
* Unregulated hypertension, chronic kidney disease, irritable bowel syndrome, anemia of chronic diseases, chronic autoimmune inflammatory condition.
* Significant cardiovascular disease or congestive heart failure.
* Known allergy to yeast or any other component of BioFe.
* Received an investigational drug within 30 days of screening.
* Any laboratory abnormality, medical condition or psychiatric disorder, which in the opinion of the clinical principal investigator or Sponsor, may result in the subject being unable to comply with study requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03210168
Study Brief:
Protocol Section:
NCT03210168