BioFe, Medical Food for the Dietary Management of Iron Deficiency

NCT03210168 | Completed

• 1 other identifier: 327736
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Iron Deficiency

Outcome Measures

Primary Outcomes (1)

• 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

  10 Weeks

Secondary Outcomes (1)

• Correction of Iron Deficiency

  10 Weeks

Study Arms (1)

BioFe Medical Food

EXPERIMENTAL

Escalating consumption of BioFe in a single cohort of up to 40 subjects with iron deficiency.

Other: BioFe Medical Food

Interventions

BioFe Medical Food OTHER

BioFe is comprised of cultured nutritional/Baker's yeast (Saccharomyces cerevisiae) with high levels of Ferritin/Iron complex, pasteurized, and dried

BioFe Medical Food

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate iron deficiency defined as transferrin saturation (TSAT) \<20% and serum ferritin \<50 ng/mL.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidero Bioscience, LLC: lead

Study Sites (3)

Green & Seidner Family Practice Associates

Lansdale, Pennsylvania, 19446, United States

Location

Frontier Clinical Research, LLC

Scottdale, Pennsylvania, 15683, United States

Location

Frontier Clinical Research, LLC

Smithfield, Pennsylvania, 15478, United States

Location

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• James Connor, PhD

  Chairman and Co-Founder

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Escalating consumption of BioFe in a single cohort of up to 40 subjects with iron deficiency.

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 6, 2017
• Study Start: July 4, 2017
• Primary Completion: December 18, 2017
• Study Completion: June 30, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)