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

Abstract

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.

Authors:
; ; ; ;
Publication Date:
Research Org.:
Univ. of Rochester, NY (USA)
OSTI Identifier:
5964569
Resource Type:
Journal Article
Resource Relation:
Journal Name: J. Pediatr.; (United States); Journal Volume: 114:5
Country of Publication:
United States
Language:
English
Subject:
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

Citation Formats

Rodewald, L.E., Maiman, L.A., Foye, H.R., Borch, R.F., and Forbes, G.B. Deuterium oxide as a tracer for measurement of compliance in pediatric clinical drug trials. United States: N. p., 1989. Web. doi:10.1016/S0022-3476(89)80159-3.
Rodewald, L.E., Maiman, L.A., Foye, H.R., Borch, R.F., & Forbes, G.B. Deuterium oxide as a tracer for measurement of compliance in pediatric clinical drug trials. United States. doi:10.1016/S0022-3476(89)80159-3.
Rodewald, L.E., Maiman, L.A., Foye, H.R., Borch, R.F., and Forbes, G.B. Mon . "Deuterium oxide as a tracer for measurement of compliance in pediatric clinical drug trials". United States. doi:10.1016/S0022-3476(89)80159-3.
@article{osti_5964569,
title = {Deuterium oxide as a tracer for measurement of compliance in pediatric clinical drug trials},
author = {Rodewald, L.E. and Maiman, L.A. and Foye, H.R. and Borch, R.F. and Forbes, G.B.},
abstractNote = {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.},
doi = {10.1016/S0022-3476(89)80159-3},
journal = {J. Pediatr.; (United States)},
number = ,
volume = 114:5,
place = {United States},
year = {Mon May 01 00:00:00 EDT 1989},
month = {Mon May 01 00:00:00 EDT 1989}
}