NCT00368732

Brief Summary

Each year in the United States, thousands of babies are born with heart defects. Women who take folic acid during pregnancy have a lower risk of giving birth to infants with heart defects, but the reason for this remains unknown. This study will examine the relationship between genes, nutrition, and the occurrence of heart defects in infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,610

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

July 29, 2016

Status Verified

December 1, 2007

First QC Date

August 24, 2006

Last Update Submit

July 28, 2016

Conditions

Heart Defects, Congenital

Keywords

Congenital Heart Defects

Eligibility Criteria

AgeUp to 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Mothers of babies with heart defects and mothers of babies without any malformation.

You may qualify if:

  • Conotruncal heart defect

You may not qualify if:

  • If part of control group, must not have heart defect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Birth Defects Monitoring Program

Berkeley, California, 94710, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Buccal cell collection

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Gary M. Shaw, DrPH

    California Birth Defects Monitoring Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

August 24, 2006

First Posted

August 25, 2006

Study Start

July 1, 2006

Study Completion

December 1, 2006

Last Updated

July 29, 2016

Record last verified: 2007-12

Locations

US(1)