DATA COORDINATING CENTER: PEDIATRIC RENAL DISEASE STUDY

Project: Research project

Project Details

Description

The Data Coordinating Center (DDC) will continue to be responsible for all
data management and biostatistical analysis in the recently funded
extension for the "Growth Failure in Children with Renal Diseases" (GFRD)
Clinical Trial. The DCC identifies and controls extraneous sources of
variability, ensures the accuracy, reliability, validity and completeness
of all anthropometric, nutritional and laboratory data and provides expert
analysis and interpretation. The GFRD Clinical Trial is a multi-center,
randomized triple-masked control study to determine differences in
treatment effect (1, 25-dihydroxyvitamin D3 or dihydrotachysterol) on
linear growth and complications of treatment. Eligible patients are
initially enrolled in a 6-month Control Period (to provide baseline data
and to ascertain compliance) and are then randomized to a Treatment Period
for at least 6 months and up to 5 1/2 years. The DCC monitors compliance
with the GFRD Manual of Operations, the comprehensive document developed
during the planning period, updated as needed and presently used by Clinic
Directors, Data Managers and Clinic Dietitians at all participating
centers. This is accomplished by daily/weekly telephone contacts, site
visits as required and one or two additional Training/Orientation Sessions
for all participants. Data recorded on GFRD forms are sent to the DCC,
logged in, visually reviewed, entered, verified and edited through
"EasyEntry", further edited using SAS then organized and backed up on the
VAX through SAS. During the "analysis" year, interim and final analyses of
clinical trial data will be presented in several areas. (Three interim
analyses have been completed to date: at least one more is scheduled.)
Multivariate growth curve analysis will be used to test differences in
linear height between treatment groups; multiple regression techniques will
be employed in the analysis of reciprocal serum creatinine (and glomerular
filtration rates); multivariate proportional hazards analysis will be used
to compare treatment complications such as hypercalcemia between groups.
StatusFinished
Effective start/end date2/1/9012/31/90

Funding

  • NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

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