Dietary Intervention Study in Children (DISC)
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| ClinicalTrials.gov Identifier: NCT00000459 |
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Recruitment Status :
Completed
First Posted : October 28, 1999
Last Update Posted : May 5, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiovascular Diseases Heart Diseases Hypercholesterolemia | Behavioral: diet, fat-restricted | Phase 3 |
BACKGROUND:
Several lines of evidence provided the rationale for intervening in children. A large body of autopsy and pathologic evidence had accumulated showing that atherosclerosis, including fatty streaks, increased surface involvement, and advanced microscopic lesions, began in childhood. Blood cholesterol levels tracked from childhood to adulthood, with tracking correlations ranging from .6 to .8. Therefore, a high proportion of children with high levels of cholesterol have high levels as adults. Family clustering of risk factors had also been reported. Studies showed 2-3 times increased prevalence of coronary heart disease in adult relatives of children with high cholesterol compared to children with normal cholesterol, and 2.2 times increased prevalence in high cholesterol in children who had a parent or grandparent with premature coronary heart disease compared with children who did not have a family history of premature heart disease. Finally, there was high likelihood that environmental influences on coronary heart disease risk factors had their behavioral antecents in childhood. Thus, dietary habits which contributed toward elevated blood cholesterol levels were likely to have developed early in life, and it was hoped that behavioral change achieved during childhood was likely to persist into adulthood.
Although numerous studies had shown that dietary modification could lower blood cholesterol levels in adults, only a few studies had shown this effect in children, and none were long-term. Furthermore, the impact on long-term growth and development in children had not been studied. Concerns were raised about the safety of cholesterol-lowering diets in children, particularly during peak growing years. These concerns included possible deficits in growth and nutrient adequacy, and potential adverse psychological effects. This paucity of data was a potential barrier to active prevention measures. To fill this gap in knowledge, the DISC trial, a randomized, controlled clinical trial, tested the efficacy and safety of long-term dietary intervention for reduction of serum LDL-C levels in children during puberty.
DESIGN NARRATIVE:
In the feasibility study, children of both sexes, ages 8 to 10 at baseline starting in 1987, were randomized to either a control group or to a usual care group for whom more intensive dietary intervention for the child and the family was directed. The feasibility study lasted 16 months. The full-scale trial began in December 1988 with the randomization of a total of 663 children. At baseline, mean LDL-C levels, nutrient intakes, anthropometric measurements, nutritional biochemical levels, and psychosocial measures were similar in the two groups. The intervention group was assigned to a series of group and individual sessions to teach the children and their families to follow a diet containing 28 percent of calories as total fat, dietary cholesterol intake less than 75 mg/1000 kcal, and up to 9% of calories from polyunsaturated fat. The diets were designed to meet nutritional requirements of growing children. The usual care group was provided a packet of general dietary information only. The primary efficacy outcome was a difference in changes in LDL-C levels between the two groups at 36 months. Primary safety endpoints were change in height and serum ferritin levels. Secondary safety outcomes included serum zinc, retinol, albumin levels, red blood cell folate, ratio of LDL-C to high-density lipoprotein cholesterol, sexual maturation, cognitive development, and psychosocial assessments. Recruitment was completed in July 1990. Intervention and follow-up was extended until 1997 when the participants were on average 17 years old. Data analysis continued through January 1999.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
| Study Type : | Interventional (Clinical Trial) |
| Allocation: | Randomized |
| Primary Purpose: | Prevention |
| Study Start Date : | December 1986 |
| Actual Study Completion Date : | January 1999 |
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| Ages Eligible for Study: | 8 Years to 10 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000459
| OverallOfficial: | Bruce Barton | Maryland Medical Research Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00000459 |
| Other Study ID Numbers: |
48 U01HL037947 ( U.S. NIH Grant/Contract ) U01HL037948 ( U.S. NIH Grant/Contract ) U01HL037954 ( U.S. NIH Grant/Contract ) U01HL037962 ( U.S. NIH Grant/Contract ) U01HL037966 ( U.S. NIH Grant/Contract ) U01HL037975 ( U.S. NIH Grant/Contract ) U01HL038110 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 28, 1999 Key Record Dates |
| Last Update Posted: | May 5, 2016 |
| Last Verified: | March 2005 |
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Cardiovascular Diseases Heart Diseases Hypercholesterolemia Hyperlipidemias |
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |