Genetic and Nutritional Causes of Heart Birth Defects

Heart Defects, Congenital Clinical Trial

Official title:

Gene and Nutrient Etiologies of Human Heart Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00368732
• Other study ID #: 1352
• Secondary ID: R01HL085859
• Status: Completed
• Phase: N/A
• First received: August 24, 2006
• Last updated: July 28, 2016
• Start date: July 2006
• Est. completion date: December 2006

Study information

• Verified date: December 2007
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1610
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

Inclusion Criteria:

• Conotruncal heart defect

Exclusion Criteria:

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital

Locations

Country	Name	City	State
United States	California Birth Defects Monitoring Program	Berkeley	California

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States,