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BioFe, Medical Food for the Dietary Management of Iron Deficiency

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ClinicalTrials.gov Identifier: NCT03210168
Recruitment Status : Active, not recruiting
First Posted : July 6, 2017
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Sidero Bioscience, LLC

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

Condition or disease Intervention/treatment Phase
Iron Deficiency Other: BioFe Medical Food Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
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
Official Title: A Clinical Trial of BioFe, Medical Food for the Dietary Management of Iron Deficiency
Actual Study Start Date : July 4, 2017
Actual Primary Completion Date : December 18, 2017
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: BioFe Medical Food
Escalating consumption of BioFe in a single cohort of up to 40 subjects with iron deficiency.
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Correction of Iron Deficiency [ Time Frame: 10 Weeks ]
    Increase in Serum Iron Measurements Ferritin, Iron, And TSAT



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210168


Locations
United States, Pennsylvania
Green & Seidner Family Practice Associates
Lansdale, Pennsylvania, United States, 19446
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, United States, 15683
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, United States, 15478
Sponsors and Collaborators
Sidero Bioscience, LLC
Investigators
Study Director: James Connor, PhD Chairman and Co-Founder

Responsible Party: Sidero Bioscience, LLC
ClinicalTrials.gov Identifier: NCT03210168     History of Changes
Other Study ID Numbers: 327736
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases