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Relation of Diet to Serum Homocysteine Level in Youths

Relation of Diet to Serum Homocysteine Level in Youths

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00037466
Enrollment
2445
Registered
2002-05-17
Start date
2000-09-30
Completion date
2002-11-30
Last updated
2016-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Cardiovascular Diseases, Heart Diseases

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 U.S. 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 U.S. with folic acid and its impact on the distribution of tHcy levels in adolescents described. Effective January 1, 1998, the U.S. 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.

Interventions

None listed

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Boston Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

The subjects for this analysis were had to be part of CATCH, a trial designed to evaluate the effectiveness of a multi-component school-based cardiovascular health promotion intervention, described elsewhere in detail(29-30). The main trial (1991-1994) was conducted among students in grades 3-5 attending 96 public elementary schools (56 intervention and 40 control schools) in California, Louisiana, Minnesota, and Texas. Following the main trial, two observational studies were conducted that measured physiologic and behavioral risk factors in study participants from grades 6 to 8 (1994-1997) (pre-fortification) and in grade 12 (post-fortification) (2000-2001).

Design outcomes

Primary

MeasureTime frame
Serum homocysteine (tHcy) concentrations4 years
Serum folic acid concentrations4 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026