Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340366
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Influence of Genetics on Vitamin Metabolism in Pregnant Women
Sponsor:
National Human Genome Research Institute NHGRI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Investigation Into the Influence of Genetic Variation on Folate Cobalamin and Related Metabolites
Status:
COMPLETED
Status Verified Date:
2007-12-10
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:
This study will examine how the body metabolizes micronutrients such vitamins during pregnancy and how genetic make-up influences their metabolism Vitamin B12 and folate levels in pregnancy have been linked to birth defects such as neural tube defects orofacial clefts and congenital heart disease Other micronutrient levels may be related to other birth defects or pregnancy complications This study will characterize the patterns of micronutrient status during pregnancy and compare it with genetic variants and biochemical parameters Information about the relationship between genes and vitamin metabolism may help doctors advise women about their nutritional requirements during pregnancy to protect their health and the health of their babies
This study is a collaboration between NIH and Trinity College in Dublin Ireland Women of Irish origin 18 years of age or older who are receiving prenatal care at the Coombe Womens Hospital in Dublin may be enrolled Fathers also may participate
Upon entering the study female participants complete a questionnaire relating to their food and vitamin intake alcohol consumption smoking behavior and use of medications and provide a blood sample Additional blood samples are collected during routine clinic visits at about 24 and 34 weeks of pregnancy and again at delivery and from 6 weeks to 2 months after the babys birth Permission will be requested to obtain a blood sample from the umbilical cord at birth after it has been removed from the baby
Fathers of the babies are also asked to answer a short questionnaire and to provide a DNA sample for genetic studies To collect the DNA sterile cotton swabs are rubbed around the inside of the mouth to obtain cheek cells from which the DNA is extracted
This study is a collaboration between NIH and Trinity College in Dublin Ireland Women of Irish origin 18 years of age or older who are receiving prenatal care at the Coombe Womens Hospital in Dublin may be enrolled Fathers also may participate
Upon entering the study female participants complete a questionnaire relating to their food and vitamin intake alcohol consumption smoking behavior and use of medications and provide a blood sample Additional blood samples are collected during routine clinic visits at about 24 and 34 weeks of pregnancy and again at delivery and from 6 weeks to 2 months after the babys birth Permission will be requested to obtain a blood sample from the umbilical cord at birth after it has been removed from the baby
Fathers of the babies are also asked to answer a short questionnaire and to provide a DNA sample for genetic studies To collect the DNA sterile cotton swabs are rubbed around the inside of the mouth to obtain cheek cells from which the DNA is extracted
Detailed Description:
A number of genetic polymorphisms influence human folate vitamin B12 and related micronutrient levels Vitamin B12 and folate levels in pregnancy have been linked to birth defects including neural tube defects orofacial clefts and congenital heart disease Additionally related analytes such as homocysteine may be related to birth defects and pregnancy complications The behavior of maternal serum micronutrients and related analytes throughout human pregnancy is not well described In this study we aim to characterize the patterns of micronutrient status during pregnancy We plan to perform biochemical analyses on serial blood samples collected from 500 pregnant women at five intervals spanning early pregnancy and the post partum period We will also characterize neonatal micronutrient status using a specimen of umbilical cord blood These blood specimens as well as buccal swab specimens collected from the fathers will also be evaluated to measure the influence of genetic variants on metabolite levels The major outcomes measured will be longitudinal maternal micronutrient levels and aggregate alleel frequencies among family triads Comparisons will be made between the presence of genetic variants biochemical parameters and clinical phenotype At a later date we also plan to study the same metabolic and genetic parameters in a large cohort of healthy individuals Characterizing these biochemical and genetic variants should provide insight into the metabolic processes of normal and complicated pregnancies
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 |
|---|---|---|---|
| 04-HG-N068 | None | None | None |