Genetic and Nutritional Causes of Heart Birth Defects | NCT00368732

Studies
Genetic and Nutritional Causes of Heart Birth Defects

NCT00368732

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Status

Completed

Last Update Posted

Jul 29, 2016Estimated

Enrollment

1,610Actual

Phase

Not provided

Conditions

Heart Defects, Congenital

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01HL085859	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Not provided

Completion Date

Dec 2006Actual

First Submitted Date

Aug 24, 2006

First Submission Date that Met QC Criteria

Aug 24, 2006

First Posted Date

Aug 25, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2016

Last Update Posted Date

Jul 29, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

National Heart, Lung, and Blood Institute (NHLBI)NIH

Collaborators

Not provided

Description Module

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.

Detailed Description

Congenital heart defects are the most common type of birth defect; each year, more than 30,000 babies in the United States are born with this kind of abnormality. Conotruncal heart defects, considered to be a very serious type of defect, involve a structural abnormality in the chambers of the heart or blood vessels that lead to and from the heart. Infants born with conotruncal defects must undergo complex open heart surgery, and there is a high fatality rate. Folic acid supplementation during pregnancy has been shown to reduce the risk of conotruncal defects. However, some women who take folic acid during pregnancy still give birth to infants with conotruncal defects. Specific genes may influence the way individuals metabolize folic acid, and variations in these genes may make some infants more prone to developing heart defects. This study will examine the relationship between genes, maternal nutritional intake, and conotruncal heart defects. The results from this study may help to determine genetic and nutritional causes of congenital heart defects.

This study will use previously collected data on 550 infants born with conotruncal defects and 1060 infants born without heart defects. There will be no study visits specifically for this study. Infant DNA will be analyzed for genes that may play a role in folate metabolic pathways. Blood previously collected from the mothers during pregnancy will be analyzed for differences in nutrient intake. Specifically, levels of folic acid, choline, vitamin B12, and methionine will be examined.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,610Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Conotruncal heart defect

Exclusion Criteria:

If part of control group, must not have heart defect

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

12 Months

Standard Ages

Child

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gary M. Shaw, DrPH	California Birth Defects Monitoring Program	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
California Birth Defects Monitoring Program		Berkeley	California	94710	United States

References Module

Citations

Not provided

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities