Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368732
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2006-08-24
Brief Title:
Genetic and Nutritional Causes of Heart Birth Defects
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
Gene and Nutrient Etiologies of Human Heart Defects
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 30000 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL085859 | NIH | None | httpsreporternihgovquickSearchR01HL085859 |