Long-term safety and efficacy of a cholesterol-lowering diet in children with elevated low-density lipoprotein cholesterol: Seven-year results of theDietary Intervention Study in Children (DISC)

Objective. Diets reduced in fat and cholesterol are recommended for childre n over 2 years of age, yet long-term safety and efficacy are unknown. This study tests the long-term efficacy and safety of a cholesterol-lowering die tary intervention in children. Methods. Six hundred sixty-three children 8 to 10 years of age with elevate d low-density lipoprotein cholesterol (LDL-C) were randomized to a dietary intervention or usual care group, with a mean of 7.4 years' followup. The d ietary behavioral intervention promoted adherence to a diet with 28% of ene rgy from total fat, <8% from saturated fat, up to 9% from polyunsaturated f at, and <75 mg/1000 kcal cholesterol per day. Serum LDL-C, height, and seru m ferritin were primary efficacy and safety outcomes. Results. Reductions in dietary total fat, saturated fat, and cholesterol we re greater in the intervention than in the usual care group throughout the intervention period. At 1 year, 3 years, and at the last visit, the interve ntion compared with the usual care group had 4.8 mg/dL (.13 mmol/L), 3.3 mg /dL (.09 mmol/L), and 2.0 mg/dL (.05 mmol/L) lower LDL-C, respectively. The re were no differences at any data collection point in height or serum ferr itin or any differences in an adverse direction in red blood cell folate, s erum retinol and zinc, sexual maturation, or body mass index. Conclusion. Dietary fat modification can be achieved and safely sustained i n actively growing children with elevated LDL-C, and elevated LDL-C levels can be improved significantly up to 3 years. Changes in the usual care grou p's diet suggest that pediatric practices and societal and environmental fo rces are having positive public health effects on dietary behavior during a dolescence.