Dietary Intervention Study in Children (DISC)
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Accession Number
HLB00400524a
Study Type
Clinical Trial
Collection Type
Open BioLINCC Study
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Study Period
1986-1999
NHLBI Division
DCVS
Dataset(s) Last Updated
January 24, 2024
Clinical Trial URLs
https://clinicaltrials.gov/ct2/show/NCT00000459
Primary Publication URLs
https://www.ncbi.nlm.nih.gov/pubmed/7723156
Related Studies
DISC06
Consent
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
Commercial Use Specimen Restrictions No
Non-Genetic Use Specimen Restrictions Based On Area Of Use No
Genetic Use Of Specimens Allowed? Yes
Genetic Use Area Of Research Restrictions No
Specific Consent Restrictions
None.
Available Data
Data available for request include DISC main study data as well as hormone and metabolomics data.
Objectives
The Dietary Intervention Study in Children (DISC) trial was initiated in 1987 and sought to evaluate the efficacy and safety of a lipid lowering diet in 8 to 10 year old children after at least 3 years of followup. The primary efficacy outcome was low-density lipoprotein (LDL) cholesterol. Secondary efficacy outcomes were total cholesterol, high-density lipoprotein (HDL), cholesterol, and triglycerides. Primary safety outcomes were height and serum ferritin. Secondary safety outcomes included serum zinc, folate, retinol, and albumin. The trial was extended, with continuation of the intervention, albeit at a diminished intensity, to follow the children for an additional 4 years, resulting in a mean of 7.4 years of total follow-up, when the participants were on average 17 years old.
Background
A growing body of evidence suggests that atherosclerosis is a long term process that may begin early in childhood. Autopsy studies have revealed coronary fatty streaks in obese children, and other studies have shown that blood cholesterol levels show a fairly high correlation as children age into young adults. Familial clustering of lipid levels provide further rationale for intervention studies aimed at reducing cholesterol levels in children. Previous studies have demonstrated the efficacy of dietary interventions in adults in reducing blood cholesterol levels; however, the safety and efficacy of dietary interventions in growing children were less clear, and previous studies were only short-term interventions.
Participants
The DISC study was a multicenter, randomized controlled trial that enrolled 663 prepubertal children aged 8 to 10 years who had elevated LDL-cholesterol levels (80th-98th percentile based on age-gender distributions from the Lipid Research Clinics). The children were assigned at random to an intervention or usual care group. Fifty-five percent of the participants were male. The intervention group attended a series of group and individual sessions where the children and their families were counseled to follow a diet containing 28 percent of calories as total fat, less than 8 percent of calories from saturated 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 educational publications on heart-healthy eating that were generally available to the public. The primary endpoint was change in LDL-cholesterol after three years of followup, and subsequently after 7 years of follow-up.
Conclusions
After three years of followup, LDL cholesterol decreased by an average of 15.4 mg/dL in the intervention group and 11.9 mg/dL in the usual care group. This difference of 3.3 mg/dL (adjusted for baseline levels and gender) was significant (p=0.02). There were no significant differences between the two groups in adjusted mean height or serum ferritin. There were no significant differences in secondary safety measures as well. (JAMA, 1995; 273(18):1429-35). After 7 years of followup, the difference in LDL-cholesterol between the two treatment groups decreased to 2.0 mg/dL, which was no longer significant. There continued to be no significant differences in an adverse direction in primary or secondary safety measures. (Pediatrics, 2001;107(2):256-264).
Additional Details
Intervention: 334
Usual care: 329
Intervention | Usual Care | All | ||||
---|---|---|---|---|---|---|
N | % | N | % | N | % | |
8 | 81 | 24.25 | 79 | 24.01 | 160 | 24.13 |
9 | 169 | 50.60 | 163 | 49.54 | 332 | 50.08 |
10 | 84 | 25.15 | 87 | 26.44 | 171 | 25.79 |
Intervention | Usual Care | All | ||||
---|---|---|---|---|---|---|
N | % | N | % | N | % | |
Male | 179 | 53.59 | 183 | 55.62 | 362 | 54.60 |
Female | 155 | 46.41 | 146 | 44.38 | 301 | 45.40 |
Intervention | Usual Care | All | ||||
---|---|---|---|---|---|---|
N | % | N | % | N | % | |
White | 289 | 86.53 | 285 | 86.63 | 574 | 86.58 |
Black | 25 | 7.49 | 31 | 9.42 | 56 | 8.45 |
Other | 20 | 5.99 | 13 | 3.95 | 33 | 4.98 |
Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request. Section 3 of the BioLINCC handbook describes the components of the review process
10/22/2019
Serum | Total | |
---|---|---|
Screening Visit 1 | 976 | 976 |
Screening Visit 2 | 1,756 | 1,756 |
Baseline | 9 | 9 |
Intervention Visit | 254 | 254 |
Month 6 | 276 | 276 |
Month 12 | 1,417 | 1,417 |
Month 27 | 1 | 1 |
Month 36 | 3,602 | 3,602 |
Month 37 | 1,779 | 1,779 |
Month 48 | 542 | 542 |
Year 5 | 1,858 | 1,858 |
Year 6 | 4 | 4 |
Year 7 | 1,128 | 1,128 |
Final Visit 1 | 3,263 | 3,263 |
Final Visit 2 (Repeat) | 91 | 91 |
Unknown | 3 | 3 |
10/22/2019
Serum | ||
---|---|---|
Total number of subjects | Average volume (ml) per subject | |
Screening Visit 1 | 408 | 1.42 |
Screening Visit 2 | 638 | 1.53 |
Baseline | 7 | 8.14 |
Intervention Visit | 83 | 6.08 |
Month 6 | 105 | 1.19 |
Month 12 | 507 | 1.33 |
Month 27 | 1 | 2.00 |
Month 36 | 599 | 6.77 |
Month 37 | 472 | 2.22 |
Month 48 | 87 | 3.74 |
Year 5 | 446 | 2.53 |
Year 6 | 1 | 6.10 |
Year 7 | 229 | 3.40 |
Final Visit 1 | 554 | 3.91 |
Final Visit 2 (Repeat) | 45 | 1.08 |
Unknown | 1 | 3.00 |
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Resources Available
Specimens and Study DatasetsMaterials Available
- Serum
- More Details
Study Documents
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