Safety and Tolerability of BioFe for Iron Deficiency Management

Iron Deficiency Clinical Trial

Official title: A Clinical Study of the Safety and Tolerability of BioFe, A Medical Food for the Management of Iron Deficiency

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

• NCT number: NCT03484026
• Study type: Interventional
• Source: Sidero Bioscience, LLC
• Status: Completed
• Phase: N/A
• Start date: May 17, 2018
• Completion date: June 30, 2020