Dietary intervention study in children (DISC) with elevated low-density-lipoprotein cholesterol. Design and baseline characteristics. DISC Collaborative Research Group.

The Dietary Intervention Study in Children (DISC) is a multicenter prospective study designed to assess the efficacy and safety of a lipid-lowering diet in 8- to 10-year-old children with moderately elevated low-density-lipoprotein cholesterol (LDL-C) levels. Six-hundred sixty-three children were randomized to a dietary intervention group (n = 334) and a usual-care group (n = 329). At baseline, mean LDL-C levels, nutrient intakes, anthropometric measures, and blood pressures were similar in the two groups. The intervention consists of a series of group and individual sessions to teach children and their families to follow a diet containing 28% of calories as total fat (< 8% as saturated fat, up to 9% as polyunsaturated fat, 11% as monounsaturated fat) and dietary cholesterol intake less than 75 mg/1000 kcal (< 150 mg/d) and designed to meet nutritional requirements of growing children. The usual-care group was provided with a packet of general dietary information only. Efficacy of the intervention will be assessed by comparing changes in LDL-C levels between the two groups at 36 months. Primary safety outcome assessments will involve comparisons of linear growth and serum ferritin levels. Secondary safety outcomes include serum zinc, folate, retinol, and albumin levels; ratio of LDL-C to high-density-lipoprotein cholesterol; sexual maturation; cognitive development; and child behavior. Thus, DISC aims to address long-term efficacy and concerns about the overall safety of dietary modifications in growing children.

RCT Entities:   Population Interventions Outcomes