We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Relation of Diet to Serum Homocysteine Level in Youths

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00037466
First Posted: May 17, 2002
Last Update Posted: March 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Voula Osganian, Children's Hospital Boston
  Purpose
To examine the relation between diet and plasma total homocysteine levels in an ethnically and geographically diverse cohort of adolescents.

Condition
Cardiovascular Diseases Heart Diseases Atherosclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relation of Diet to Serum Homocysteine Level in Youths

Further study details as provided by Voula Osganian, Children's Hospital Boston:

Primary Outcome Measures:
  • Serum homocysteine (tHcy) concentrations [ Time Frame: 4 years ]
  • Serum folic acid concentrations [ Time Frame: 4 years ]

Enrollment: 2445
Study Start Date: September 2000
Study Completion Date: November 2002
Primary Completion Date: August 2001 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The CATCH study initially recruited 5,106 third grade students to participate in a risk factor screening at baseline. Of these, 3645 (71%) participated in risk factor screening at the end of grade 8 when serum tHcy, folate, vitamin B6 and vitamin B12 were first assessed and 2909 (57%) students participated in the follow-up risk factor screening in grade 12. Of these students, 2445, attended both grade 8 and grade 12 examinations and provided blood at both examinations. This group constituted the study population for this report.
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00037466


Sponsors and Collaborators
Boston Children’s Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Stavroula Osganian, MD, ScD Boston Children’s Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Voula Osganian, Associate Professor of Pediatrics, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00037466     History of Changes
Other Study ID Numbers: 1173
R01HL066643 ( U.S. NIH Grant/Contract )
First Submitted: May 16, 2002
First Posted: May 17, 2002
Last Update Posted: March 3, 2016
Last Verified: February 2005
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data Sharing was not required at the time the study was conducted.

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases