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Relation of Diet to Serum Homocysteine Level in Youths

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ClinicalTrials.gov Identifier: NCT00037466
Recruitment Status : Completed
First Posted : May 17, 2002
Last Update Posted : March 3, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Voula Osganian, Boston Children’s Hospital

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

Condition or disease
Cardiovascular Diseases Heart Diseases Atherosclerosis

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.


Study Type : Observational
Actual Enrollment : 2445 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relation of Diet to Serum Homocysteine Level in Youths
Study Start Date : September 2000
Actual Primary Completion Date : August 2001
Actual Study Completion Date : November 2002



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


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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).

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

Additional Information:
Publications of Results:
Responsible Party: Voula Osganian, Associate Professor of Pediatrics, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT00037466     History of Changes
Other Study ID Numbers: 1173
R01HL066643 ( U.S. NIH Grant/Contract )
First Posted: May 17, 2002    Key Record Dates
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