Safety and Tolerability of BioFe for Iron Deficiency Management

Completed · Not applicable

Conditions studied: Iron Deficiency

In brief

This study evaluates the safety, tolerability, and activity of BioFe in the dietary management of iron deficiency in adults.

Key facts

Study ID

NCT03484026

Run by

Sidero Bioscience, LLC

People needed

6

Starts

2018-05-17

Expected to finish

2020-06-30

Last updated by the study team

2020-07-02

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Moderate iron deficiency defined as transferrin saturation (TSAT) <20% and serum ferritin <50 ng/mL.

You may not qualify if…

• 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.

Where it is running

• Pennsylvania State University College of Medicine Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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