Safety and Tolerability of BioFe for Iron Deficiency Management
Condition: Iron Deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

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.
    

Intervention name(s): BioFe
Intervention type(s): Dietary Supplement
Intervention description(s): BioFe Medical Food is comprised of cultured nutritional/Baker's yeast (Saccharomyces cerevisiae) with high levels of Ferritin/Iron complex, pasteurized, and dried
Intervention model: Single Group Assignment
Intervention model description: Consumption of BioFe in a single cohort of up to 8 subjects with iron deficiency.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Iron Deficiency; Anemia; Medical Food