Relation of Diet to Serum Homocysteine Level in Youths

Cardiovascular Diseases Clinical Trial

Official title:

Relation of Diet to Serum Homocysteine Level in Youths

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00037466
• Other study ID #: 1173
• Secondary ID: R01HL066643
• Status: Completed
• Phase: N/A
• First received: May 16, 2002
• Last updated: March 1, 2016
• Start date: September 2000
• Est. completion date: November 2002

Study information

• Verified date: February 2005
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

To examine the relation between diet and plasma total homocysteine levels in an ethnically and geographically diverse cohort of adolescents.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2445
• Est. completion date: November 2002
• Est. primary completion date: August 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Heart Diseases

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

References & Publications (1)

Enquobahrie DA, Feldman HA, Hoelscher DH, Steffen LM, Webber LS, Zive MM, Rimm EB, Stampfer MJ, Osganian SK. Serum homocysteine and folate concentrations among a US cohort of adolescents before and after folic acid fortification. Public Health Nutr. 2012 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum homocysteine (tHcy) concentrations		4 years	No
Primary	Serum folic acid concentrations		4 years	No

External Links

•   Final Results Paper