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Efficacy and Safety of Lowering Dietary Intake of Fat and Cholesterol in Children With Elevated Low-Density Lipoprotein Cholesterol The Dietary Intervention Study in Children (DISC)

Peter O. Kwiterovich, MD; Ginny Hartmuller, MS; Linda Van Horn, PhD; Katherine K. Christoffel, MD; Niki Gernhoffer, MS; Samuel Gidding, MD; John V. Lavigne, PhD; Ronald M. Lauer, MD; Linda Snetselaar, PhD; Patti Steinmuller, MS; Lynette Stickney; Norman L. Lasser, MD, PhD; Rhonda F. Greenberg, PsyD; Patricia Kennedy, MA; Vera I. Lasser, MA; Alan M. Robson, MD; Frank A. Franklin, MD, PhD; Kristian Von Almen, PhD; Victor J. Stevens, PhD; Shirley Craddick, MS; Merwyn R. Greenlick, PhD; Jacob A. Reiss, MD; Bruce A. Barton, PhD; Kathleen Brown, PhD; Paul L. Canner, PhD; Sue Y. S. Kimm, MD; Robert McMahon, PhD; Eva Obarzanek, PhD; Jeffrey A. Cutler, MD; Marguerite A. Evans, MS; Marilyn Farrand Zukel, MS; Sally A. Hunsberger, PhD; Edward Lakatos, PhD; Nancy C. Santanello, MD; Denise G. Simons-Morton, MD, PhD; Paul S. Bachorik, PhD; Elaine W. Gunter; I. Marilyn Buzzard, PhD
JAMA. 1995;273(18):1429-1435. doi:10.1001/jama.1995.03520420045036.
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Objective.  —To assess the efficacy and safety of lowering dietary intake of total fat, saturated fat, and cholesterol to decrease low-density lipoprotein cholesterol (LDL-C) levels in children.

Design.  —Six-center randomized controlled clinical trial.

Participants.  —Prepubertal boys (n=362) and girls (n=301) aged 8 to 10 years with LDL-C levels greater than or equal to the 80th and less than the 98th percentiles for age and sex were randomized into an intervention group (n=334) and a usual care group (n=329).

Intervention.  —Behavioral intervention to promote adherence to a diet providing 28% of energy from total fat, less than 8% from saturated fat, up to 9% from polyunsaturated fat, and less than 75 mg/4200 kJ (1000 kcal) per day of cholesterol (not to exceed 150 mg/d).

Main Outcome Measures.  —The primary efficacy measure was the mean LDL-C level at 3 years. Primary safety measures were mean height and serum ferritin levels at 3 years. Secondary efficacy outcomes were mean LDL-C levels at 1 year and mean total cholesterol levels at 1 and 3 years. Secondary safety outcomes included red blood cell folate values; serum zinc, retinol, and albumin levels; serum high-density lipoprotein cholesterol (HDL-C) values, LDL-C:HDL-C ratio, and total triglyceride levels; sexual maturation; and psychosocial health.

Results.  —At 3 years, dietary total fat, saturated fat, and cholesterol levels decreased significantly in the intervention group compared with the usual care group (all P<.001). Levels of LDL-C decreased in the intervention and usual care groups by 0.40 mmol/L (15.4 mg/dL) and 0.31 mmol/L (11.9 mg/dL), respectively. Adjusting for baseline level and sex and imputing values for missing data, the mean difference between the groups was —0.08 mmol/L (—3.23 mg/dL) (95% confidence interval [CI], —0.15 to —0.01 mmol/L [—5.6 to —0.5 mg/dL]), which was significant (P=.02). There were no significant differences between the groups in adjusted mean height or serum ferritin levels (P>.05) or other safety outcomes.

Conclusions.  —The dietary intervention achieved modest lowering of LDL-C levels over 3 years while maintaining adequate growth, iron stores, nutritional adequacy, and psychological well-being during the critical growth period of adolescence.(JAMA. 1995;273:1429-1435)


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