Red Blood Cell Precursor Formulation to Determine Increased Production
| Status: | Withdrawn |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 5/6/2016 |
| Start Date: | October 2012 |
| End Date: | May 2014 |
An Open-Label, Pilot Study of a Red Blood Cell Precursor Formulation to Determine Increased Production in Subjects With Mild to Moderate Anemia
The objective of this study is to measure the change in hemoglobin levels after the
administration of an amino acid based, RBC precursor formulation.
administration of an amino acid based, RBC precursor formulation.
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.
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.
Inclusion Criteria:
1. M/F patients 18 to 75 years old, non-pregnant/lactating
2. Male patients with < Hemoglobin of 12.5
3. Female Patients with < Hemoglobin of 11
4. Diagnosis of mild to moderate anemia by study physician
Exclusion Criteria:
1. Pregnant or unwilling to use adequate birth control for the duration of the study.
2. Unwilling or unable to sign informed consent.
3. Myocardial infarction within the last 6 months.
4. Patients currently taking an erythropoietin medication and unable to discontinue for
the duration of the study.
5. GI bleed in the last 6 months.
6. Inflammatory bowel disease.
7. Chronic liver disease.
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