Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000459
Status:
COMPLETED
Last Update Posted:
2016-05-05
First Post:
1999-10-27
Brief Title:
Dietary Intervention Study in Children DISC
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the feasibility acceptability efficacy and safety of dietary intervention in free-living children ages 8-10 with elevated low density lipoprotein cholesterol levels
Detailed Description:
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 22 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 mg1000 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
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 22 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 mg1000 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL038110 | NIH | None | httpsreporternihgovquickSearchU01HL038110 |
| U01HL037947 | NIH | None | None |
| U01HL037948 | NIH | None | None |
| U01HL037954 | NIH | None | None |
| U01HL037962 | NIH | None | None |
| U01HL037966 | NIH | None | None |
| U01HL037975 | NIH | None | None |