NCT03484026

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 17, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

July 2, 2020

Status Verified

June 1, 2020

Enrollment Period

11 months

First QC Date

March 24, 2018

Last Update Submit

June 30, 2020

Conditions

Iron Deficiency

Keywords

Iron DeficiencyAnemiaMedical Food

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

    18 Weeks

Secondary Outcomes (1)

  • Correction of Iron Deficiency

    18 Weeks

Study Arms (1)

BioFe Medical Food

EXPERIMENTAL

Consumption of BioFe Medical Food in a single cohort of up to 8 female subjects with iron deficiency.

Dietary Supplement: BioFe

Interventions

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

BioFe Medical Food

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennsylvania State University College of Medicine Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Links

MeSH Terms

Conditions

Iron DeficienciesAnemia

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Darren Wolfe, PhD

    Sidero Bioscience, LLC

    STUDY CHAIR

  • James R Connor, PhD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Consumption of BioFe in a single cohort of up to 8 subjects with iron deficiency.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2018

First Posted

March 30, 2018

Study Start

May 17, 2018

Primary Completion

March 31, 2019

Study Completion

June 30, 2020

Last Updated

July 2, 2020

Record last verified: 2020-06

Locations

US(1)