DIETARY INTERVENTION STUDY IN CHILDREN (DISC II)

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The Dietary Intervention Study in Children (DISC) is a multi-center, randomized controlled clinical trial of dietary intervention to lower LDL-cholesterol level (LDL-C) in 663 children who were 8-10 years of age and Tanner Stage I at baseline. This proposal seeks to extend the study for an additional seven years to investigate the long-term safety, efficacy, feasibility and acceptability of a diet modified in total fat, saturated fat and dietary cholesterol initiated in pre-pubescence and continued throughout adolescence. During DISC I, the Chicago DISC Center successfully recruited and randomized 116 eligible children, 16 more than the goal of 100 children per each of the six centers. DISC I is completing the sixth of its funded seven years, consisting initially of seven months of planning and protocol development, (Phase I), followed by seventeen months of feasibility testing (Phase II), and then the full scale dietary intervention trial with follow-up ranging between 36-60 months depending upon the time of randomization (Phase III). Phase IV was originally planned for data analyses and reporting. This proposal involves continuation of the study until children reach 18 years of age, through completion of puberty and achievement of at or near adult stature so that final growth, stature and maturation resulting from the fat modified diet can be assessed. A central proposal detailing the design, data collection, current progress and preliminary results for entire study has been submitted by the DISC Coordinating Center. This proposal is specific to the Chicago DISC Center and its role in DISC II as a clinical center.