Deuterium oxide as a tracer for measurement of compliance in pediatric clinical drug trials

Journal Article · Mon May 01 00:00:00 EDT 1989 · J. Pediatr.; (United States)

DOI:https://doi.org/10.1016/S0022-3476(89)80159-3· OSTI ID:5964569

Rodewald, L E; Maiman, L A; Foye, H R; Borch, R F; Forbes, G B

We tested the hypothesis that a deuterium oxide (D/sub 2/O) tracer could discriminate among patterns of clinically significant, imperfect compliance during drug trials. A model was developed to predict deuterium concentration during multiple dose regimens. After developing a regression equation to predict one of the model parameters for children, we selected healthy children (N = 20) at random to receive one of five 10-day D/sub 2/O regimens. Five urine samples were obtained from each child during 15 days and analyzed for deuterium level by mass spectrometry. Each child's height, weight, age, and the first four urinary deuterium levels were used to estimate the amount and timing of deuterium administration. These estimates were compared with the five regimens to determine the closest match between estimate and regimen. The closest matching regimen was the regimen actually administered to 19 (95%) of the 20 children. Two of these children had D/sub 2/O administration estimates that could be confused with another regimen. The correlation between the model's predicted levels and the measured levels of all urine samples was 0.96. We conclude that a D/sub 2/O tracer shows excellent promise as a quantitative method of assessing compliance with liquid medications under specified conditions.

• Research Organization: Univ. of Rochester, NY (USA)
• OSTI ID: 5964569
• Journal Information: J. Pediatr.; (United States), Vol. 114:5
• Country of Publication: United States
• Language: English

Related Subjects

59 BASIC BIOLOGICAL SCIENCES
DRUGS
METABOLISM
CHILDREN
DEUTERIUM
FORECASTING
MATHEMATICAL MODELS
PATIENTS
TRACER TECHNIQUES
URINE
AGE GROUPS
BIOLOGICAL MATERIALS
BIOLOGICAL WASTES
BODY FLUIDS
HYDROGEN ISOTOPES
ISOTOPE APPLICATIONS
ISOTOPES
LIGHT NUCLEI
MATERIALS
NUCLEI
ODD-ODD NUCLEI
STABLE ISOTOPES
WASTES
550501* - Metabolism- Tracer Techniques