A Trial to Evaluate the Safety and Tolerability of a Nove... | NCT03038633

NCT03038633

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Measure	Description	Time Frame
Dose-limiting toxicity, (DLT)	Still evaluating data	28 Days

Eligibility Module

Eligibility Criteria

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

ID	Term
D000747	Anemia, Hypochromic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases