Genetic and Nutritional Causes of Heart Birth Defects
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|ClinicalTrials.gov Identifier: NCT00368732|
Recruitment Status : Completed
First Posted : August 25, 2006
Last Update Posted : July 29, 2016
|Condition or disease|
|Heart Defects, Congenital|
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.
|Study Type :||Observational|
|Actual Enrollment :||1610 participants|
|Observational Model:||Case Control|
|Official Title:||Gene and Nutrient Etiologies of Human Heart Defects|
|Study Start Date :||July 2006|
|Actual Study Completion Date :||December 2006|
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): NCT00368732
|United States, California|
|California Birth Defects Monitoring Program|
|Berkeley, California, United States, 94710|
|Principal Investigator:||Gary M. Shaw, DrPH||California Birth Defects Monitoring Program|