Influence of Genetics on Vitamin Metabolism in Pregnant Women

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00340366
First received: June 19, 2006
Last updated: March 5, 2008
Last verified: December 2007
  Purpose

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.


Condition
Pregnancy
Birth Defects

Study Type: Observational
Official Title: Investigation Into the Influence of Genetic Variation on Folate, Cobalamin and Related Metabolites

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Study Start Date: December 2003
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00340366

Locations
Ireland
The Coombe Maternity Hospital
Dublin, Ireland
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00340366     History of Changes
Other Study ID Numbers: 999904068, 04-HG-N068
Study First Received: June 19, 2006
Last Updated: March 5, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Homocysteine
Vitamin B12
Birth Defects
Pregnancy
Folate
Irish Individuals

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on October 23, 2014