AsthmaNCT00454415
Prospective Study of Dietary Factors, BMI, and Risk of Asthma in Children
An observational study of Asthma, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Asthma is a common illness among children in the United States. While there are many known causes of asthma, including tobacco smoke, pollen, dust, or other allergens, the exact cause of asthma in some individuals remains unknown. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 16,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2008
- 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 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: U.S. children
Who may be able to join
- Children of women in the Nurses Health Study II (NHS2)
- Participated in the Growing Up Today study
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Channing Laboratory, Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Asthma is a common illness among children in the United States. While there are many known causes of asthma, including tobacco smoke, pollen, dust, or other allergens, the exact cause of asthma in some individuals remains unknown. This study will examine the role that specific dietary factors and body mass index (BMI) play in the development of childhood asthma.
Read the detailed description
Asthma prevalence has steadily increased in the United States since the early 1980s, but the exact cause of this increase remains unknown. It is estimated that at least 8% of Americans have asthma. Although anti-inflammatory medications have proven effective for decreasing asthma exacerbations, there are few treatment options available to prevent the initial onset of the disease. Dietary factors and BMI may play a role in the development of asthma. Specifically, individuals who eat foods containing antioxidants (e.g., vitamin C, vitamin E, and carotenoids), n-3 polyunsaturated fatty acids (e.g., fish oils), and vitamin D may have a decreased risk of developing asthma, while individuals with higher BMI ratios may have an increased asthma risk. The purpose of this study is to evaluate the relationship among dietary factors, BMI, and the incidence of asthma among children.
This study will enroll children participating in the Growing Up Today study and children of nurses who are participating in the Nurses Health Study II. Researchers will analyze participants' previously completed questionnaires on dietary intake, physical activity, height, weight, and the presence of physician-diagnosed asthma. All participants with physician-diagnosed asthma will receive an additional asthma questionnaire. A small portion of these participants will also have their medical records reviewed by study researchers, and mothers of these children will be asked to complete a questionnaire. Additionally, a questionnaire will be sent to and completed by children who do not have asthma and their mothers.
- Conditions
- Asthma
- Keywords
- Diet, Body Mass Index, BMI
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
incident asthma
Measured: childhood
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2007 (estimated)
- Study startJan 2007
- Primary completionDec 2008
- Study completionDec 2008
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.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- 16,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Carlos A. Camargo, Brigham and Women's Hospital
- Investigators
- Carlos A. Camargo, MD, DrPH, Principal investigator, Channing Laboratory, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454415
- Sponsor's protocol ID
- 1376
- Other IDs
- R01HL084401-01A1
- Status last verified
- Dec 2012
- First submitted
- 28 Mar 2007
- Last updated
- 27 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Dietary Factors, BMI, and Risk of Asthma in Children
- ClinicalTrials.gov ID
- NCT00454415
- Acronym / sponsor ID
- 1376
- Conditions
- Asthma
- Keywords
- Diet, Body Mass Index, BMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16,000 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 30 Mar 2007 (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.
Asthma is a common illness among children in the United States. While there are many known causes of asthma, including tobacco smoke, pollen, dust, or other allergens, the exact cause of asthma in some individuals remains unknown. This study will examine the role that specific dietary factors and body mass index (BMI) play in the development of childhood asthma.
Detailed description
Asthma prevalence has steadily increased in the United States since the early 1980s, but the exact cause of this increase remains unknown. It is estimated that at least 8% of Americans have asthma. Although anti-inflammatory medications have proven effective for decreasing asthma exacerbations, there are few treatment options available to prevent the initial onset of the disease. Dietary factors and BMI may play a role in the development of asthma. Specifically, individuals who eat foods containing antioxidants (e.g., vitamin C, vitamin E, and carotenoids), n-3 polyunsaturated fatty acids (e.g., fish oils), and vitamin D may have a decreased risk of developing asthma, while individuals with higher BMI ratios may have an increased asthma risk. The purpose of this study is to evaluate the relationship among dietary factors, BMI, and the incidence of asthma among children.
This study will enroll children participating in the Growing Up Today study and children of nurses who are participating in the Nurses Health Study II. Researchers will analyze participants' previously completed questionnaires on dietary intake, physical activity, height, weight, and the presence of physician-diagnosed asthma. All participants with physician-diagnosed asthma will receive an additional asthma questionnaire. A small portion of these participants will also have their medical records reviewed by study researchers, and mothers of these children will be asked to complete a questionnaire. Additionally, a questionnaire will be sent to and completed by children who do not have asthma and their mothers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- U.S. children
Key inclusion criteria (2 listed)
- Children of women in the Nurses Health Study II (NHS2)
- Participated in the Growing Up Today study
Key exclusion criteria (1 listed)
- None
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
incident asthma
Time frame: childhood
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 27 Dec 2012.
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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.
Carlos A. Camargo, MD, DrPH principal investigator
Channing Laboratory, Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
incident asthma (time frame: childhood). 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 27 Dec 2012.