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BioFe, Medical Food for the Dietary Management of Iron Deficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210168
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Sidero Bioscience, LLC

Tracking Information
First Submitted Date  ICMJE June 26, 2017
First Posted Date  ICMJE July 6, 2017
Last Update Posted Date July 2, 2020
Actual Study Start Date  ICMJE July 4, 2017
Actual Primary Completion Date December 18, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2017)
Safety and Tolerability as the number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 10 Weeks ]
Blood cell, blood chemistry, and stool sample analysis. Health questionnaires including GI symptoms, fatigue, and quality of life by the Short Form 36 (SF-36) questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2017)
Correction of Iron Deficiency [ Time Frame: 10 Weeks ]
Increase in Serum Iron Measurements Ferritin, Iron, And TSAT
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BioFe, Medical Food for the Dietary Management of Iron Deficiency
Official Title  ICMJE A Clinical Trial of BioFe, Medical Food for the Dietary Management of Iron Deficiency
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 serious and widespread misconception that oral iron supplements are safe and effective at alleviating iron deficiency. In a recent Cochrane review of 67 clinical trials, women taking oral iron supplements had a mere 38% decreased risk of iron deficiency compared to placebo. On the contrary, these subjects had a 114% increased risk of side effects, the vast majority of which were associated with gastrointestinal (GI) disturbance.

In infants and children, iron deficiency impedes mental, motor, and auditory neuronal development leading to serious lifelong cognitive and physical deficiencies. In adults, iron deficiency, and associated iron deficiency anemia, cause extreme fatigue, decreased immune system function and increased susceptibility to infectious disease, reduced work capacity, dizziness, headaches, hair loss, and generalized reduced quality of life. Iron deficiency is also linked to Restless Leg Syndrome (RLS), adult hearing deficits, reduced strength, coordination, and endurance, anxiety, increased heart failure morbidity, decreased intellectual performance, and erectile dysfunction among many others conditions.

Most iron deficient people are not effectively treated by, or are intolerant to, oral iron supplements. Intravenous iron repletion drugs effective, but are also costly and onerous to deliver leading to both patient and payor dissatisfaction.

BioFe, Medical Food for Iron Deficiency is nutritional/Baker's yeast (Saccharomyces cerevisiae), expressing the Ferritin protein. Ferritin is an indispensable iron storage, transport and absorption protein normally produced at low levels by almost all living organisms. An illustrative example of the biology of the Ferritin/Iron complex is its presence in human breast milk, providing infants the natural biological iron required for rapid learning and development, without gastrointestinal upset. BioFe provides high level expression of Ferritin that is naturally complexed with iron during culture, is pasteurized, and dried.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Escalating consumption of BioFe in a single cohort of up to 40 subjects with iron deficiency.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Iron Deficiency
Intervention  ICMJE Other: BioFe Medical Food
BioFe is comprised of cultured nutritional/Baker's yeast (Saccharomyces cerevisiae) with high levels of Ferritin/Iron complex, pasteurized, and dried
Study Arms  ICMJE Experimental: BioFe Medical Food
Escalating consumption of BioFe in a single cohort of up to 40 subjects with iron deficiency.
Intervention: Other: BioFe Medical Food
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2018)
34
Original Estimated Enrollment  ICMJE
 (submitted: July 4, 2017)
40
Actual Study Completion Date  ICMJE June 30, 2020
Actual Primary Completion Date December 18, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03210168
Other Study ID Numbers  ICMJE 327736
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sidero Bioscience, LLC
Study Sponsor  ICMJE Sidero Bioscience, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: James Connor, PhD Chairman and Co-Founder
PRS Account Sidero Bioscience, LLC
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP