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

NCT03038633 | Completed Phase 1

• 1 other identifier: 34696
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity, (DLT)

  Still evaluating data

  28 Days

Study Arms (4)

Cohort 1

EXPERIMENTAL

900 mg novel medical food containing 22.2mg iron * receive 900 mg by mouth (3 capsules, one at each meal) daily; after Day 28 remain on level for additional 2 months if clinically indicated * receive a phone call from coordinator between Day 5-9 to assess side effects and medications * return to General Clinical Research Center, (GCRC) for a blood draw at days 14, 28, 60, and 90 while on novel medical food

Other: Novel Medical Food

Cohort 2

EXPERIMENTAL

1800 mg novel medical food containing 44.4 mg of iron * receive 1800 mg by mouth (3 capsules, one at each meal) daily; after Day 28 remain on level for additional 2 months if clinically indicated * receive a phone call from coordinator between Day 5-9 to assess side effects and medications * return to GCRC for a blood draw at days 14, 28, 60, and 90 while on novel medical food

Other: Novel Medical Food

Cohort 3

EXPERIMENTAL

2700 mg novel medical food containing 66.6 mg of iron * receive 2700 mg by mouth (3 capsules, one at each meal) daily; after Day 28 remain on level for additional 2 months if clinically indicated * receive a phone call from coordinator between Day 5-9 to assess side effects and medications * return to GCRC for a blood draw at days 14, 28, 60, and 90 while on novel medical food

Other: Novel Medical Food

Cohort 4

EXPERIMENTAL

3600 mg novel medical food containing 88.8 mg of iron * receive 3600 mg by mouth (3 capsules, one at each meal) daily; after Day 28 remain on level for additional 2 months if clinically indicated * receive a phone call from coordinator between Day 5-9 to assess side effects and medications * return to GCRC for a blood draw at days 14, 28, 60, and 90 while on novel medical food

Other: Novel Medical Food

Interventions

Novel Medical Food OTHER

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.

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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).
• 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.
• 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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffesor of Medicine

Model Details: Individuals will receive 300 mg capsules of the novel medical food. The iron content of these capsules is 7.4mg. Our initial dose is set at 22.2 mg of iron. This dose was chosen as the initial starting dose because it is within the range of the RDA for iron for adult women (18mg). Thus this dose is considered the minimum that would be utilized in any setting for maintenance of a healthy iron status. The dosing increases to a maximum of 88.8mg of iron per day which is significantly below the standard amount of iron (165-195mg per day) recommended for an iron deficient individual or the amount of iron given intravenously (1000 mg) for some iron deficient conditions. As mentioned, the total element iron given a patient treated with FAS is up to 190mg of iron. Assuming a 10% absorption rate these patients get 19mg of iron. So if our goal is approximately 19mg of iron absorbed per day and we assume a 50% absorption rate then our target dose is 6-9 capsules per day (44.4-66.6 mg iron).

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: January 31, 2017
• Study Start: May 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

US (1)