Iron DeficiencyNCT03484026
Safety and Tolerability of BioFe for Iron Deficiency Management
A study testing BioFe in people with Iron Deficiency, run by Sidero Bioscience, LLC at 1 site in United States.
Trial summary
This study evaluates the safety, tolerability, and activity of BioFe in the dietary management of iron deficiency in adults. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- BioFe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate iron deficiency defined as transferrin saturation (TSAT) <20% and serum ferritin <50 ng/mL.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennsylvania State University College of Medicine Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: A Clinical Study of the Safety and Tolerability of BioFe, A Medical Food for the Management of Iron Deficiency
This study evaluates the safety, tolerability, and activity of BioFe in the dietary management of iron deficiency in adults.
Read the 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.
- Conditions
- Iron Deficiency
- Being tested
- BioFe
- Keywords
- Iron Deficiency, Anemia, Medical Food
- Medical subject headings
- Iron Deficiencies, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioFeDietary supplement
BioFe Medical Food is comprised of cultured nutritional/Baker's yeast (Saccharomyces cerevisiae) with high levels of Ferritin/Iron complex, pasteurized, and dried
| Study group | Role | What they receive |
|---|---|---|
| BioFe Medical Food | Experimental | Consumption of BioFe Medical Food in a single cohort of up to 8 female subjects with iron deficiency. Receives: Dietary Supplement: BioFe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability as the number of participants with treatment-related adverse events as assessed by CTCAE v4.03
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
Measured: 18 Weeks
Secondary outcomes (1)
Correction of Iron Deficiency
Increase in Serum Iron Measurements Ferritin, Iron, and TSAT
Measured: 18 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start17 May 2018
- Primary completion31 Mar 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Consumption of BioFe in a single cohort of up to 8 subjects with iron deficiency.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidero Bioscience, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Milton S. Hershey Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Darren Wolfe, PhD, Study chair, Sidero Bioscience, LLCJames R Connor, PhD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484026
- Sponsor's protocol ID
- 743376
- Other IDs
- 1R41DK105656-01A1
- Status last verified
- Jun 2020
- First submitted
- 24 Mar 2018
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of the Safety and Tolerability of BioFe, A Medical Food for the Management of Iron Deficiency
- ClinicalTrials.gov ID
- NCT03484026
- Acronym / sponsor ID
- 743376
- Conditions
- Iron Deficiency
- Keywords
- Iron Deficiency, Anemia, Medical Food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Sidero Bioscience, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Milton S. Hershey Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 May 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Consumption of BioFe in a single cohort of up to 8 subjects with iron deficiency.
| Arm | Type | Receives |
|---|---|---|
| BioFe Medical Food | Experimental | Dietary Supplement: BioFeConsumption of BioFe Medical Food in a single cohort of up to 8 female subjects with iron deficiency. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate iron deficiency defined as transferrin saturation (TSAT) <20% and serum ferritin <50 ng/mL.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioFeBioFe Medical Food is comprised of cultured nutritional/Baker's yeast (Saccharomyces cerevisiae) with high levels of Ferritin/Iron complex, pasteurized, and dried | Dietary supplement | BioFe Medical Food |
Primary outcome
Safety and Tolerability as the number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time frame: 18 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
1 secondary outcome
Correction of Iron Deficiency
Time frame: 18 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Sidero Bioscience WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Wolfe, PhD study chair
Sidero Bioscience, LLC
James R Connor, PhD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioFe in people with Iron Deficiency, run by Sidero Bioscience, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability as the number of participants with treatment-related adverse events as assessed by CTCAE v4.03 (time frame: 18 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.