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
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency||Other: BioFe Medical Food||Not Applicable|
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|
|Actual Study Completion Date :||June 30, 2020|
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
- 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
- Correction of Iron Deficiency [ Time Frame: 10 Weeks ]Increase in Serum Iron Measurements Ferritin, Iron, And TSAT
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
|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|
|Study Director:||James Connor, PhD||Chairman and Co-Founder|