Red Blood Cell Precursor Formulation to Determine Increased Production

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to measure the change in hemoglobin levels after the administration of an amino acid based, RBC precursor formulation.

Detailed Description
-----------------
Medical foods are a distinct FDA regulatory category different from single molecule chemical pharmaceuticals, and from dietary supplements. The FDA has regulated amino acid preparations as drugs since the 1940s as they can elicit pharmacologic effects similar to conventional single molecule pharmaceuticals. The best known amino acid preparations are used to treat conditions such as maple syrup disease and phenylketonuria (PKU). An official definition and categorization of medical foods was made in 1988 as part of the Orphan Drug Act. Medical foods are regulated similarly to drugs except they do not require pre-approval because all ingredients are found on the FDA's generally recognized as safe (GRAS) (Sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act) list and claims are confined to the nutritional management of a specific disease. Medical food claims must be supported by recognized scientific data as determined by medical evaluation. A GRAS substance is distinguished from a food additive on the basis of the common knowledge about the safety of the substance for its intended use. The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition of safety through widespread usage and agreement of that safety by experts in the field. Many ingredients have been determined by the FDA to be GRAS, and are listed as such by regulation, in Volume 21 Code of Federal Regulations (CFR) Sections 182, 184, and 186.

Official Title
-----------------
An Open-Label, Pilot Study of a Red Blood Cell Precursor Formulation to Determine Increased Production in Subjects With Mild to Moderate Anemia

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: RBCPF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F patients 18 to 75 years old, non-pregnant/lactating Male patients with < Hemoglobin of 12.5 Female Patients with < Hemoglobin of 11 Diagnosis of mild to moderate anemia by study physician Exclusion Criteria: Pregnant or unwilling to use adequate birth control for the duration of the study. Unwilling or unable to sign informed consent. Myocardial infarction within the last 6 months. Patients currently taking an erythropoietin medication and unable to discontinue for the duration of the study. GI bleed in the last 6 months. Inflammatory bowel disease. Chronic liver disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RBCPF<br>Treatment intervention arm | Drug: RBCPF<br> <br> * Other names: Red blood cell precursor formulation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin level 2 hours after administration of the first dose. | Subjects will have blood drawn at baseline and 2 hours after the administration of the treatment intervention. Then again, after 7 days. | Baseline, 2 hours and 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CBC w/ differential |  | Baseline, 2 hours and 7 days | 
| Erythropoietin level |  | Baseline, 2 hours and 7 days | 
| Reticulocytes |  | Baseline, 2 hours and 7 days | 
| Iron levels |  | Baseline, 2 hours and 7 days | 
| Ferritin |  | Baseline, 2 hours and 7 days | 
| IGG |  | Baseline, 2 hours and 7 days | 
| B12 |  | Baseline, 2 hours and 7 days |