Lung DiseasesNCT00006404
Nutrition in Pregnancy, Birth Weight, and Childhood Asthma
An observational study of Lung Diseases and Asthma, run by Harvard Pilgrim Health Care.
Trial summary
To evaluate the role of maternal diet and birth weight in the etiology of childhood asthma and other allergic disorders. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Diseases, Asthma
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2000to Jul 2006
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To evaluate the role of maternal diet and birth weight in the etiology of childhood asthma and other allergic disorders.
Read the detailed description
BACKGROUND:
Asthma is one of the most common chronic diseases diagnosed among children in the developed world, and its prevalence in western industrialized countries is increasing at an alarming rate. Little information is currently available regarding the role of maternal diet during pregnancy and birth weight in the risk of childhood asthma.
DESIGN NARRATIVE:
This longitudinal prospective study takes advantage of the resources provided by Project Viva, an ongoing prospective cohort study of pregnant women and their infant offspring among members of Harvard Pilgrim Health Care, a large managed care organization in New England. Data already available from Project Viva include detailed dietary data on mother and infant, along with data on anthropometric, social, environmental, demographic, economic, psychological, and lifestyle variables. The study will follow the Project Viva cohort until ages 3 to 4 years.
- Conditions
- Lung Diseases, Asthma
- Medical subject headings
- Lung Diseases, Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2000 (estimated)
- Study startSep 2000
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies 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
Sponsor and investigators
- Lead sponsor
- Harvard Pilgrim Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Matthew Gillman, Harvard Pilgrim Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006404
- Sponsor's protocol ID
- 929
- Other IDs
- R01HL064925
- Status last verified
- May 2009
- First submitted
- 12 Oct 2000
- Last updated
- 26 Mar 2014
- Results posted
- No
Publications
Oken E, Kleinman KP, Berland WE, Simon SR, Rich-Edwards JW, Gillman MW. Decline in fish consumption among pregnant women after a national mercury advisory. Obstet Gynecol. 2003 Aug;102(2):346-51. doi: 10.1016/s0029-7844(03)00484-8.
PubMed 12907111Oken E, Gillman MW. Fetal origins of obesity. Obes Res. 2003 Apr;11(4):496-506. doi: 10.1038/oby.2003.69.
PubMed 12690076Gillman MW. Epidemiological challenges in studying the fetal origins of adult chronic disease. Int J Epidemiol. 2002 Apr;31(2):294-9. No abstract available.
PubMed 11980782Schroeter CH, Schaub B, Gold DR, Contreras PJ, Manrique O, Gillman MW, Weiss S, Palmer LJ, Perkins D, Finn PW. Nuclear factor kappa B activation in human cord blood mononuclear cells. Pediatr Res. 2004 Aug;56(2):212-8. doi: 10.1203/01.PDR.0000132850.33375.D0. Epub 2004 Jun 4.
PubMed 15181194Mone SM, Gillman MW, Miller TL, Herman EH, Lipshultz SE. Effects of environmental exposures on the cardiovascular system: prenatal period through adolescence. Pediatrics. 2004 Apr;113(4 Suppl):1058-69.
PubMed 15060200Moore MM, Rifas-Shiman SL, Rich-Edwards JW, Kleinman KP, Camargo CA Jr, Gold DR, Weiss ST, Gillman MW. Perinatal predictors of atopic dermatitis occurring in the first six months of life. Pediatrics. 2004 Mar;113(3 Pt 1):468-74. doi: 10.1542/peds.113.3.468.
PubMed 14993536Gillman MW, Rich-Edwards JW, Rifas-Shiman SL, Lieberman ES, Kleinman KP, Lipshultz SE. Maternal age and other predictors of newborn blood pressure. J Pediatr. 2004 Feb;144(2):240-5. doi: 10.1016/j.jpeds.2003.10.064.
PubMed 14760269Taveras EM, Scanlon KS, Birch L, Rifas-Shiman SL, Rich-Edwards JW, Gillman MW. Association of breastfeeding with maternal control of infant feeding at age 1 year. Pediatrics. 2004 Nov;114(5):e577-83. doi: 10.1542/peds.2004-0801. Epub 2004 Oct 18.
PubMed 15492358Oken E, Kleinman KP, Olsen SF, Rich-Edwards JW, Gillman MW. Associations of seafood and elongated n-3 fatty acid intake with fetal growth and length of gestation: results from a US pregnancy cohort. Am J Epidemiol. 2004 Oct 15;160(8):774-83. doi: 10.1093/aje/kwh282.
PubMed 15466500Gillman MW, Rifas-Shiman SL, Kleinman KP, Rich-Edwards JW, Lipshultz SE. Maternal calcium intake and offspring blood pressure. Circulation. 2004 Oct 5;110(14):1990-5. doi: 10.1161/01.CIR.0000143199.93495.96. Epub 2004 Sep 27.
PubMed 15451777Schaub B, Bellou A, Gibbons FK, Velasco G, Campo M, He H, Liang Y, Gillman MW, Gold D, Weiss ST, Perkins DL, Finn PW. TLR2 and TLR4 stimulation differentially induce cytokine secretion in human neonatal, adult, and murine mononuclear cells. J Interferon Cytokine Res. 2004 Sep;24(9):543-52. doi: 10.1089/jir.2004.24.543.
PubMed 15450130Celi AC, Rich-Edwards JW, Richardson MK, Kleinman KP, Gillman MW. Immigration, race/ethnicity, and social and economic factors as predictors of breastfeeding initiation. Arch Pediatr Adolesc Med. 2005 Mar;159(3):255-60. doi: 10.1001/archpedi.159.3.255.
PubMed 15753269
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition in Pregnancy, Birth Weight, and Childhood Asthma
- ClinicalTrials.gov ID
- NCT00006404
- Acronym / sponsor ID
- 929
- Conditions
- Lung Diseases, Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Harvard Pilgrim Health CareUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2000
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 13 Oct 2000 (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 evaluate the role of maternal diet and birth weight in the etiology of childhood asthma and other allergic disorders.
Detailed description
BACKGROUND:
Asthma is one of the most common chronic diseases diagnosed among children in the developed world, and its prevalence in western industrialized countries is increasing at an alarming rate. Little information is currently available regarding the role of maternal diet during pregnancy and birth weight in the risk of childhood asthma.
DESIGN NARRATIVE:
This longitudinal prospective study takes advantage of the resources provided by Project Viva, an ongoing prospective cohort study of pregnant women and their infant offspring among members of Harvard Pilgrim Health Care, a large managed care organization in New England. Data already available from Project Viva include detailed dietary data on mother and infant, along with data on anthropometric, social, environmental, demographic, economic, psychological, and lifestyle variables. The study will follow the Project Viva cohort until ages 3 to 4 years.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 26 Mar 2014.
- Background: PubMed 12907111Oken E, Kleinman KP, Berland WE, Simon SR, Rich-Edwards JW, Gillman MW. Decline in fish consumption among pregnant women after a national mercury advisory. Obstet Gynecol. 2003 Aug;102(2):346-51. doi: 10.1016/s0029-7844(03)00484-8.
- Background: PubMed 12690076Oken E, Gillman MW. Fetal origins of obesity. Obes Res. 2003 Apr;11(4):496-506. doi: 10.1038/oby.2003.69.
- Background: PubMed 11980782Gillman MW. Epidemiological challenges in studying the fetal origins of adult chronic disease. Int J Epidemiol. 2002 Apr;31(2):294-9. No abstract available.
- Background: PubMed 15181194Schroeter CH, Schaub B, Gold DR, Contreras PJ, Manrique O, Gillman MW, Weiss S, Palmer LJ, Perkins D, Finn PW. Nuclear factor kappa B activation in human cord blood mononuclear cells. Pediatr Res. 2004 Aug;56(2):212-8. doi: 10.1203/01.PDR.0000132850.33375.D0. Epub 2004 Jun 4.
- Background: PubMed 15060200Mone SM, Gillman MW, Miller TL, Herman EH, Lipshultz SE. Effects of environmental exposures on the cardiovascular system: prenatal period through adolescence. Pediatrics. 2004 Apr;113(4 Suppl):1058-69.
- Background: PubMed 14993536Moore MM, Rifas-Shiman SL, Rich-Edwards JW, Kleinman KP, Camargo CA Jr, Gold DR, Weiss ST, Gillman MW. Perinatal predictors of atopic dermatitis occurring in the first six months of life. Pediatrics. 2004 Mar;113(3 Pt 1):468-74. doi: 10.1542/peds.113.3.468.
- Background: PubMed 14760269Gillman MW, Rich-Edwards JW, Rifas-Shiman SL, Lieberman ES, Kleinman KP, Lipshultz SE. Maternal age and other predictors of newborn blood pressure. J Pediatr. 2004 Feb;144(2):240-5. doi: 10.1016/j.jpeds.2003.10.064.
- Background: PubMed 15492358Taveras EM, Scanlon KS, Birch L, Rifas-Shiman SL, Rich-Edwards JW, Gillman MW. Association of breastfeeding with maternal control of infant feeding at age 1 year. Pediatrics. 2004 Nov;114(5):e577-83. doi: 10.1542/peds.2004-0801. Epub 2004 Oct 18.
- Background: PubMed 15466500Oken E, Kleinman KP, Olsen SF, Rich-Edwards JW, Gillman MW. Associations of seafood and elongated n-3 fatty acid intake with fetal growth and length of gestation: results from a US pregnancy cohort. Am J Epidemiol. 2004 Oct 15;160(8):774-83. doi: 10.1093/aje/kwh282.
- Background: PubMed 15451777Gillman MW, Rifas-Shiman SL, Kleinman KP, Rich-Edwards JW, Lipshultz SE. Maternal calcium intake and offspring blood pressure. Circulation. 2004 Oct 5;110(14):1990-5. doi: 10.1161/01.CIR.0000143199.93495.96. Epub 2004 Sep 27.
- Background: PubMed 15450130Schaub B, Bellou A, Gibbons FK, Velasco G, Campo M, He H, Liang Y, Gillman MW, Gold D, Weiss ST, Perkins DL, Finn PW. TLR2 and TLR4 stimulation differentially induce cytokine secretion in human neonatal, adult, and murine mononuclear cells. J Interferon Cytokine Res. 2004 Sep;24(9):543-52. doi: 10.1089/jir.2004.24.543.
- Background: PubMed 15753269Celi AC, Rich-Edwards JW, Richardson MK, Kleinman KP, Gillman MW. Immigration, race/ethnicity, and social and economic factors as predictors of breastfeeding initiation. Arch Pediatr Adolesc Med. 2005 Mar;159(3):255-60. doi: 10.1001/archpedi.159.3.255.
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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
Harvard Pilgrim Health Care, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and Asthma, 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 26 Mar 2014. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006404, which also lists 12 linked publications.
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 26 Mar 2014; AzTrials last refreshed its copy on 8 Nov 2026.