Status:
COMPLETED
Safety and Tolerability of BioFe for Iron Deficiency Management
Lead Sponsor:
Sidero Bioscience, LLC
Collaborating Sponsors:
Milton S. Hershey Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Iron Deficiency
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief Summary
This study evaluates the safety, tolerability, and activity of BioFe in the dietary management of iron deficiency in adults.
Detailed Description
Iron deficiency is the most common, widespread, and costly nutritional disorder worldwide with the World Health Organization (WHO) stating that up to 2 billion people are iron deficient. There is a se...
Eligibility Criteria
Inclusion
- Moderate iron deficiency defined as transferrin saturation (TSAT) \<20% and serum ferritin \<50 ng/mL.
Exclusion
- 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.
Key Trial Info
Start Date :
May 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03484026
Start Date
May 17 2018
End Date
June 30 2020
Last Update
July 2 2020
Active Locations (1)
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1
Pennsylvania State University College of Medicine Hershey Medical Center
Hershey, Pennsylvania, United States, 17033