Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088257
Status:
COMPLETED
Last Update Posted:
2013-12-13
First Post:
2004-07-23
Brief Title:
Maternal Fatty Acids Child Obesity and Asthma Immunity
Sponsor:
Harvard Pilgrim Health Care
Organization:
Harvard Pilgrim Health Care
Study Overview
Official Title:
Maternal Fatty Acids Child Obesity and Asthma Immunity
Status:
COMPLETED
Status Verified Date:
2013-12
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:
To study pre- and post-natal influences on the development of childhood asthma-related immune responses
Detailed Description:
BACKGROUND
Since most cases of asthma occur in the first few years of life examining its pre- and early postnatal determinants is crucial This study focuses on determinants of the developing immune system T helper cells are of two types Th1 cells participate in cell-mediated immunity essential for controlling intracellular infectious agents such as bacterial and viruses Th2 cells are essential for antibody-mediated immunity to control extracellular infectious agents The Th2 pattern characterized by higher levels of IgE increased production of proinflammatory cytokines such as interleukin-4 IL-4 or IL-13 and decreased production of interferon-gamma IFN-gamma predominates prenatally If it is not balanced by a Thl pattern after birth eg increased IFN-7 production risk of asthma likely increases Early childhood immune mechanisms associated with risk of asthma may also involve non-IgETh2 pathways with increased production of IL-6 or TNF-alpha Preliminary studies have linked asthma at various ages with reduced ratio of n-3 to n-6 polyunsaturated fatty acids increased birth weight and overweight Preliminary data have also linked these dietary and weight variables to systemic production of IgE and both Th2 and non-Th2 proinflammatory cytokines Thus allergy and inflammation may be pathways through which pre- and early postnatal dietary factors influence development of asthma However there are virtually no prospective human data linking maternal diet or fetalearly childhood growth with the asthma-related immune response in childhood
The study takes advantage of the resources of Project Viva an ongoing NIH-funded prospective cohort study of pregnant women and their offspring in eastern Massachusetts Project Viva already includes detailed dietary data on mother and infant maternal and cord blood samples and data on anthropometric social environmental demographic economic psychological and lifestyle variables Relevant covariates are included such as presence and severity of atopic diseases in the parents parental smoking infant respiratory infections and infant environment
DESIGN NARRATIVE
The study examines associations of maternal gestational n-3 and n-6 fatty acid intake fatty acid levels in umbilical cord blood fetal growth and early childhood overweight with markers of allergy and inflammation at the age of 3 years These markers include allergy-specific and total plasma IgE levels and levels of proinflammatory cytokines from antigen- and mitogen-stimulated lymphocytes This study takes advantage of the resources of Project Viva an ongoing NIH-funded prospective cohort study of pregnant women and their offspring Project Viva already includes detailed dietary data on mother and infant maternal and cord blood samples and data on anthropometric social environmental demographic economic psychological and lifestyle variables This study supports several elements not otherwise funded including adding measurement of immune outcomes at age 3 years in a subset of 370 cohort participants Given the existing infrastructure of Project Viva the study provides a relatively economical way to address scientific questions of major public health importance
Since most cases of asthma occur in the first few years of life examining its pre- and early postnatal determinants is crucial This study focuses on determinants of the developing immune system T helper cells are of two types Th1 cells participate in cell-mediated immunity essential for controlling intracellular infectious agents such as bacterial and viruses Th2 cells are essential for antibody-mediated immunity to control extracellular infectious agents The Th2 pattern characterized by higher levels of IgE increased production of proinflammatory cytokines such as interleukin-4 IL-4 or IL-13 and decreased production of interferon-gamma IFN-gamma predominates prenatally If it is not balanced by a Thl pattern after birth eg increased IFN-7 production risk of asthma likely increases Early childhood immune mechanisms associated with risk of asthma may also involve non-IgETh2 pathways with increased production of IL-6 or TNF-alpha Preliminary studies have linked asthma at various ages with reduced ratio of n-3 to n-6 polyunsaturated fatty acids increased birth weight and overweight Preliminary data have also linked these dietary and weight variables to systemic production of IgE and both Th2 and non-Th2 proinflammatory cytokines Thus allergy and inflammation may be pathways through which pre- and early postnatal dietary factors influence development of asthma However there are virtually no prospective human data linking maternal diet or fetalearly childhood growth with the asthma-related immune response in childhood
The study takes advantage of the resources of Project Viva an ongoing NIH-funded prospective cohort study of pregnant women and their offspring in eastern Massachusetts Project Viva already includes detailed dietary data on mother and infant maternal and cord blood samples and data on anthropometric social environmental demographic economic psychological and lifestyle variables Relevant covariates are included such as presence and severity of atopic diseases in the parents parental smoking infant respiratory infections and infant environment
DESIGN NARRATIVE
The study examines associations of maternal gestational n-3 and n-6 fatty acid intake fatty acid levels in umbilical cord blood fetal growth and early childhood overweight with markers of allergy and inflammation at the age of 3 years These markers include allergy-specific and total plasma IgE levels and levels of proinflammatory cytokines from antigen- and mitogen-stimulated lymphocytes This study takes advantage of the resources of Project Viva an ongoing NIH-funded prospective cohort study of pregnant women and their offspring Project Viva already includes detailed dietary data on mother and infant maternal and cord blood samples and data on anthropometric social environmental demographic economic psychological and lifestyle variables This study supports several elements not otherwise funded including adding measurement of immune outcomes at age 3 years in a subset of 370 cohort participants Given the existing infrastructure of Project Viva the study provides a relatively economical way to address scientific questions of major public health importance
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 |
|---|---|---|---|
| R01HL075504 | NIH | None | httpsreporternihgovquickSearchR01HL075504 |