Pregnancy Clinical Trial
Official title:
Investigation Into the Influence of Genetic Variation on Folate, Cobalamin and Related Metabolites
Verified date | December 10, 2007 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 Women's
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 baby's 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.
Status | Completed |
Enrollment | 0 |
Est. completion date | December 10, 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | - Eligible participants will be women of Irish origin (older than 18) presenting for prenatal care to the Coombe Women's Hospital, Dublin, Republic of Ireland. Non-Irish women (a small proportion of the population) will be excluded because the prevalence of genetic polymorphisms can vary greatly among different populations; we already have an estimate of the distribution of this genotype in the Irish women. Members of the only minority group native to Ireland, the Travelers, will not be excluded. While culturally distinct, the Travelers are genetically similar to the majority population. Women with multiple pregnancy (more than one fetus) and users of IV drugs will be excluded. Women will be asked for permission to obtain a cord blood sample from the infant at delivery. Women will be asked to assist with recruitment of their partners (father of the fetus), who will be included if they consent. |
Country | Name | City | State |
---|---|---|---|
Ireland | The Coombe Maternity Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
National Human Genome Research Institute (NHGRI) |
Ireland,
Kirke PN, Molloy AM, Daly LE, Burke H, Weir DG, Scott JM. Maternal plasma folate and vitamin B12 are independent risk factors for neural tube defects. Q J Med. 1993 Nov;86(11):703-8. — View Citation
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