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Red Blood Cell Precursor Formulation to Determine Increased Production (RBCPF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01701531
Recruitment Status : Withdrawn (Funding not received)
First Posted : October 5, 2012
Last Update Posted : May 5, 2016
Information provided by (Responsible Party):
Targeted Medical Pharma

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.

Condition or disease Intervention/treatment Phase
Anemia Drug: RBCPF Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Experimental: RBCPF
Treatment intervention arm
Other Name: Red blood cell precursor formulation

Primary Outcome Measures :
  1. Change in hemoglobin level 2 hours after administration of the first dose. [ Time Frame: Baseline, 2 hours and 7 days ]
    Subjects will have blood drawn at baseline and 2 hours after the administration of the treatment intervention. Then again, after 7 days.

Secondary Outcome Measures :
  1. CBC w/ differential [ Time Frame: Baseline, 2 hours and 7 days ]
  2. Erythropoietin level [ Time Frame: Baseline, 2 hours and 7 days ]
  3. Reticulocytes [ Time Frame: Baseline, 2 hours and 7 days ]
  4. Iron levels [ Time Frame: Baseline, 2 hours and 7 days ]
  5. Ferritin [ Time Frame: Baseline, 2 hours and 7 days ]
  6. IGG [ Time Frame: Baseline, 2 hours and 7 days ]
  7. B12 [ Time Frame: Baseline, 2 hours and 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01701531

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United States, California
Lawrence May, MD, Inc.
Tarzana, California, United States, 91356
Sponsors and Collaborators
Targeted Medical Pharma
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Principal Investigator: Lawrence May, MD Lawrence May MD, Inc
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Responsible Party: Targeted Medical Pharma Identifier: NCT01701531    
Other Study ID Numbers: RBC100312
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Hematologic Diseases