USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-93-250

Project Title:

A Comparison of Different Techniques of Body Composition Analysis to Neutron Activation Analysis in Patients on Dialysis

Principle Investigator: Dr. Ruimei Ma

Project started in: 1993

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

Non-Federal: Private donation funds

Amount: $8,000 (Est.)

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: November 02, 1994

Number of Human Subjects in the Last Reporting Period for this Project: 20
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

External use of ionizing radiation on human subjects.

• For clinical research.

Internal administration of radioactive substances to human subjects.

• For clinical research.

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

• Use of bodily materials collected from subjects specifically for this project.

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

Patients receiving dialysis frequently experience protein and caloric malnutrition. These nutritional concerns have led to new approaches to dialysis therapy. The nutritionist faced with evaluation of the dialysis patient has a compelling need to assess body composition. Until recently only anthropometric evaluation was readily available but the accuracy and reliability of this technique in dialysis patients is questionable. Additional techniques, such as Dual Photon Absorptiometry (DPA), Bioelectric Impedance (BIA) and Infrared Interactance (IR) are now clinically available but have not been validated against the gold standard (in vivo neutron activation analysis) in dialysis patients. The purpose of this pilot study is to compare the results obtained with those clinically available techniques with the results obtained by in vitro neutron activation analysis. A total of 20 subjects will be studied, only once. Elemental body compositions will be determined by whole body counting, in vivo neutron activation analysis and tritiated water dilution method. Subjects will be exposed to ionizing radiation including neutrons, gamma-rays and electrons. Subjects will be given tritiated water by mouth. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses.