NCT00037466

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,445

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2000

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2001

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2002

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
Last Updated

March 3, 2016

Status Verified

February 1, 2005

Enrollment Period

11 months

First QC Date

May 16, 2002

Last Update Submit

March 1, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Serum homocysteine (tHcy) concentrations

    4 years

  • Serum folic acid concentrations

    4 years

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related 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 Oct;15(10):1818-26. doi: 10.1017/S1368980012002984.

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesAtherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Stavroula Osganian, MD, ScD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

May 16, 2002

First Posted

May 17, 2002

Study Start

September 1, 2000

Primary Completion

August 1, 2001

Study Completion

November 1, 2002

Last Updated

March 3, 2016

Record last verified: 2005-02

Data Sharing

IPD Sharing
Will not share

Data Sharing was not required at the time the study was conducted.