Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037466
Status:
COMPLETED
Last Update Posted:
2016-03-03
First Post:
2002-05-16
Brief Title:
Relation of Diet to Serum Homocysteine Level in Youths
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Relation of Diet to Serum Homocysteine Level in Youths
Status:
COMPLETED
Status Verified Date:
2005-02
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 examine the relation between diet and plasma total homocysteine levels in an ethnically and geographically diverse cohort of adolescents
Detailed Description:
BACKGROUND
Data from observational studies suggest that plasma total homocysteine tHcy concentration may be an independent and modifiable risk factor for cardiovascular disease CVD in adults Plasma tHcy levels respond rapidly to nutrient supplementation with folic acid and vitamins Bl2 and B6 alone or in combination The available data and the potential for prevention provide a strong rationale for understanding determinants of tHcy in youth However no large US studies have examined the relation between tHcy levels to individuals dietary intakes of folic acid and vitamins Bl2 and B6 in youth
DESIGN NARRATIVE
During the Child and Adolescent Trial for Cardiovascular Health CATCH Phase 3 a cross-sectional study of serum tHcy levels was conducted in eighth grade students Jan-June 1997 Higher mean levels of plasma total homocysteine were observed among males Blacks and non-users of multi-vitamins and a strong inverse association with serum levels of folic acid and to a lesser extent with serum vitamin Bl2 A second measurement of the cohort at grade 12 was conducted in order to assess the dose-response relation between serum tHcy and dietary intakes not measured in grade 8 of folic acid vitamin B12 and vitamin B6 In addition and of equal importance changes were evaluated in serum folic acid and tHcy levels from grade 8 to 12 after full implementation of fortification of cereal and grain products in the US with folic acid and its impact on the distribution of tHcy levels in adolescents described Effective January 1 1998 the US Department of Agriculture mandated the addition of folic acid to all flour and grain products in the United States CATCH had a unique opportunity to examine the effect of this natural experiment on the distribution of serum tHcy in the cohort because serum tHcy levels were measured in grade 8 just prior to full implementation of the mandate Furthermore the study had adequate sample size to examine these changes among important demographic subgroups such as males vs females and Caucasians vs African Americans vs Hispanics Information generated by this study will be valuable for designing specific dietary interventions for youth and targeting subgroups of children who may be at higher risk for CVD
Data from observational studies suggest that plasma total homocysteine tHcy concentration may be an independent and modifiable risk factor for cardiovascular disease CVD in adults Plasma tHcy levels respond rapidly to nutrient supplementation with folic acid and vitamins Bl2 and B6 alone or in combination The available data and the potential for prevention provide a strong rationale for understanding determinants of tHcy in youth However no large US studies have examined the relation between tHcy levels to individuals dietary intakes of folic acid and vitamins Bl2 and B6 in youth
DESIGN NARRATIVE
During the Child and Adolescent Trial for Cardiovascular Health CATCH Phase 3 a cross-sectional study of serum tHcy levels was conducted in eighth grade students Jan-June 1997 Higher mean levels of plasma total homocysteine were observed among males Blacks and non-users of multi-vitamins and a strong inverse association with serum levels of folic acid and to a lesser extent with serum vitamin Bl2 A second measurement of the cohort at grade 12 was conducted in order to assess the dose-response relation between serum tHcy and dietary intakes not measured in grade 8 of folic acid vitamin B12 and vitamin B6 In addition and of equal importance changes were evaluated in serum folic acid and tHcy levels from grade 8 to 12 after full implementation of fortification of cereal and grain products in the US with folic acid and its impact on the distribution of tHcy levels in adolescents described Effective January 1 1998 the US Department of Agriculture mandated the addition of folic acid to all flour and grain products in the United States CATCH had a unique opportunity to examine the effect of this natural experiment on the distribution of serum tHcy in the cohort because serum tHcy levels were measured in grade 8 just prior to full implementation of the mandate Furthermore the study had adequate sample size to examine these changes among important demographic subgroups such as males vs females and Caucasians vs African Americans vs Hispanics Information generated by this study will be valuable for designing specific dietary interventions for youth and targeting subgroups of children who may be at higher risk for CVD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL066643 | NIH | None | httpsreporternihgovquickSearchR01HL066643 |