A Trial to Evaluate the Safety and Tolerability of a Novel Medical Food for Management of Iron Deficiency Anemia

Iron Deficiency Anemia Clinical Trial

Official title:

A Trial to Evaluate the Safety and Tolerability of a Novel Medical Food for Management of Iron Deficiency Anemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03038633
• Other study ID #: 34696
• Status: Completed
• Phase: Phase 1
• First received: October 27, 2015
• Last updated: January 30, 2017
• Start date: May 2014
• Est. completion date: June 2015

Study information

• Verified date: January 2017
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1 clinical trial designed to evaluate the safety and tolerability of a novel medical food utilizing a nutritional strain of yeast for management of Iron Deficiency Anemia.

Description:

The investigational product is a medical food and is the result of discoveries following extensive research on two preclinical models carried out by a team of researchers at Penn State University. This study will utilize the standard "3+3" rule-based dose-escalation schemes, which use predetermined dose levels and cohorts of three patients. The total time commitment for each subject is approximately three months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Hemoglobin, (Hgb) 7-10 g/dL; transferrin saturation <20%; and serum ferritin <20ng/mL

Exclusion Criteria:

• Pregnant or sexually-active female subjects who are of childbearing potential and who are 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).

• Present consumption of iron supplements or multivitamins must be switched to vitamins not containing iron, such as the multivitamin Centrum Silver. No washout period is necessary since it will be apparent from the ongoing anemia that any current supplements are ineffective.

• Current anemia not attributed to immune deficiency, (ID) (e.g. other microcytic anemia or hemolytic, macrocytic, sideroblastic or myelosuppression or chemotherapy or radiotherapy induced anemia).

• Active malignancy within 1 year. Basal or squamous cell skin cancer is not exclusionary.

• Aspartate Aminotransferase, (AST) or Alanine Aminotransferase, (ALT) at screening greater than 1.5 times the upper limit of normal.

• Known positive hepatitis B with evidence of active hepatitis.

• Known positive HIV-1/HIV-2 antibodies (anti-HIV).

• Patient has a current diagnosis of asthma and is actively using an anti-asthmatic therapy.

• Received an investigational drug within 30 days of screening.

• Hemochromatosis or other iron storage disorders.

• Unregulated hypertension

• Chronic kidney disease.

• Chronic inflammatory condition including but not limited to Lupus and Rheumatoid Arthritis.

• Significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of New York Heart Association, (NYHA) Class III or IV congestive heart failure.

• Smoking

• Irritable Bowel Syndrome

• Any other laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator puts the subject's disease management at risk or may result in the subject being unable to comply with study requirements.

• Breastfeeding planned on or after enrolling in the study.

• Known allergy to yeast

• Currently on Monoamine oxidase inhibitors, (MAOI's) or Demerol

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Other:
• Novel Medical Food
This medical food takes advantage of the stability and high level of solubility of the human H-ferritin protein to be absorbed by the body as an iron source; indeed H-ferritin is enriched in breast milk as the mechanism for transferring iron from mother to infants. Once the ferritin has been absorbed from the gut, uptake into each organ is regulated by a specific extracellular receptor pathway to deliver iron in the body's preferred bioavailable form.

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity, (DLT)	Still evaluating data	28 Days