AsthmaNCT00088257
Maternal Fatty Acids, Child Obesity, and Asthma Immunity
An observational study of Asthma and Lung Diseases, run by Harvard Pilgrim Health Care.
Trial summary
To study pre- and post-natal influences on the development of childhood asthma-related immune responses. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Asthma, Lung Diseases
- How many people
- 411 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women were recruited in 1999-2002 following their initial prenatal visit at one of eight obstetric offices of a multi-specialty group practice in eastern MA.
Women were eligible for participation in Project Viva if they:
- Were <22 weeks pregnant
- Planned to receive prenatal care at one of the selected clinics
- Planned to deliver at one of the two study hospitals
- Were able to answer questions in English
Women were ineligible if they:
- Planned to terminate their pregnancy
- Planned to move from the local area before the end of the follow-up period
- Were pregnant with multiples (twins, triplets, etc)
Project Viva mother-child pairs were eligible for this study if they had provided maternal dietary date during pregnancy and a cord blood sample at delivery on which lymphocyte proliferation had been measured.
About this study
To study pre- and post-natal influences on the development of childhood asthma-related immune responses.
Read the 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, e.g., increased IFN-7 production, risk of asthma likely increases. Early childhood immune mechanisms associated with risk of asthma may also involve non-IgE/Th2 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 fetal/early 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.
- Conditions
- Asthma, Lung Diseases
- Medical subject headings
- Asthma, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mother-child pairs | Subset of mother-child pairs enrolled in Project Viva, a cohort study of pregnant women and their offspring. 411 mother-child pairs with measures of lymphocyte proliferation in their cord blood samples make up the subset for this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of allergy and inflammation at age 3 years
Allergy-specific and total plasma IgE levels; asthma-related pro-inflammatory cytokines
Measured: Age 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2004 (estimated)
- Study startAug 2004
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Pilgrim Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Matthew W. Gillman, MD, SM, Harvard Pilgrim Health Care
- Investigators
- Matthew Gillman, Principal investigator, Harvard Pilgrim Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088257
- Sponsor's protocol ID
- 1264
- Other IDs
- R01HL075504
- Status last verified
- Dec 2013
- First submitted
- 23 Jul 2004
- Last updated
- 13 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Fatty Acids, Child Obesity, and Asthma Immunity
- ClinicalTrials.gov ID
- NCT00088257
- Acronym / sponsor ID
- 1264
- Conditions
- Asthma, Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Harvard Pilgrim Health CareUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2004
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 26 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, e.g., increased IFN-7 production, risk of asthma likely increases. Early childhood immune mechanisms associated with risk of asthma may also involve non-IgE/Th2 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 fetal/early 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mother-child pairs | – | –Subset of mother-child pairs enrolled in Project Viva, a cohort study of pregnant women and their offspring. 411 mother-child pairs with measures of lymphocyte proliferation in their cord blood samples make up the subset for this study. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women were recruited in 1999-2002 following their initial prenatal visit at one of eight obstetric offices of a multi-specialty group practice in eastern MA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Markers of allergy and inflammation at age 3 years
Time frame: Age 3 years
Allergy-specific and total plasma IgE levels; asthma-related pro-inflammatory cytokines
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Gillman principal investigator
Harvard Pilgrim Health Care
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Lung Diseases, run by Harvard Pilgrim Health Care.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Markers of allergy and inflammation at age 3 years (time frame: Age 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2013; AzTrials last refreshed its copy on 7 Nov 2026.