AsthmaNCT00851695
Examining the Role of Vitamin D in Asthma and Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Asthma and Pulmonary Disease, run by Brigham and Women's Hospital.
Trial summary
Asthma and chronic obstructive pulmonary disease (COPD) are diseases that affect a person's ability to breathe normally. People who do not receive enough vitamin D may have a higher risk of developing asthma or COPD. Read more about this study
- Who is it for?
- Ages 5 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Pulmonary Disease, Chronic Obstructive
- How many people
- 2,266 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Jun 2010
- 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 5 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: For the Childhood Asthma Management Program, the study population was children with mild to moderate asthma, 5 to 12 years of age, living across the United States. For the Genetic Epidemiology of Asthma in Costa Rica study, the study population was children with asthma, 5 to 12 years of age, living in Costa Rica. For the Normative Aging Study, the study population was a community sample of men living in the Boston area.
Who may be able to join
- Participated in the Childhood Asthma Management Program, the Genetic Epidemiology of Asthma in Costa Rica study, or the Normative Aging Study
Who cannot join
None listed.
About this study
Official title: Vitamin D in Obstructive Lung Diseases
Asthma and chronic obstructive pulmonary disease (COPD) are diseases that affect a person's ability to breathe normally. People who do not receive enough vitamin D may have a higher risk of developing asthma or COPD. This study will examine previously collected blood samples of participants in three studies to determine whether people with low vitamin D levels have an increased risk of severe asthma or COPD.
Read the detailed description
Asthma and COPD are among the leading causes of illness in children and adults, respectively. Asthma is the most common long-term disease among children in the developed world, and approximately 16 million people in the United States have COPD, which is now the fourth most common cause of death in this country. Vitamin D, both a nutrient and a hormone, can be taken in through diet and exposure to sunlight. Many children and adults have a vitamin D deficiency and there is concern that current recommended intake levels may be inadequate. A vitamin D deficiency can cause immune system dysfunction and may increase the risk of developing immune-mediated disorders, such as multiple sclerosis, inflammatory bowel disease, rheumatoid arthritis, and various cancers. Because of its role in immune development and function, a vitamin D deficiency may also be related to the development of severe asthma in children and to greater lung function decline in adults, leading to COPD. Preliminary research shows that people with asthma who take vitamin D have an enhanced response to corticosteroids, a common medication used to treat asthma. This finding suggests that vitamin D could possibly be used to improve asthma treatment. The purpose of this study is to measure vitamin D levels in participants of three previous studies and determine whether lower vitamin D levels are related to the development of severe asthma or COPD.
This study will examine previously collected blood samples from participants in three studies. There will be no study visits specifically for this study. The three studies include the following:
- Childhood Asthma Management Program, which is a study that examined the use of inhaled corticosteroids, nedocromil, and placebo in children with mild-to-moderate asthma
- Genetic Epidemiology of Asthma in Costa Rica, which is an ongoing study that is identifying genetic predictors of asthma in Costa Rican families with asthma
- Normative Aging Study, which is a study of aging that is being conducted in men living in Boston
- Conditions
- Asthma, Pulmonary Disease, Chronic Obstructive
- Keywords
- Lung Function Decline, Lung Function, Allergy, COPD, Vitamin D
- Medical subject headings
- Asthma, Lung Diseases, Hypersensitivity, Pulmonary Disease, Chronic Obstructive
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 |
|---|---|---|
| Asthma | All 1024 participants of the Childhood Asthma Management Program, who provided blood samples. | |
| Asthma in Hispanics | All 616 subjects in the Genetic Epidemiology of Asthma in Costa Rica who have serum. | |
| Lung function and lung function decline | 626 subjects from the Normative Aging Study who have serum and lung function. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma exacerbation
Measured: Measured at Year 4 in the original study
Lung function decline
Measured: Measured at Year 15 in the original study
Secondary outcomes (1)
Allergy markers
Measured: Measured at Year 4 in the original study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startJul 2007
- Primary completionJun 2010
- Study completionJun 2010
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
- Retrospective
- Enrolment
- 2,266 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, Augusto A. Litonjua, Brigham and Women's Hospital
- Investigators
- Augusto A. Litonjua, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851695
- Sponsor's protocol ID
- 1399
- Other IDs
- R21HL089842-01
- Status last verified
- Aug 2012
- First submitted
- 20 Feb 2009
- Last updated
- 13 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D in Obstructive Lung Diseases
- ClinicalTrials.gov ID
- NCT00851695
- Acronym / sponsor ID
- 1399
- Conditions
- Asthma, Pulmonary Disease, Chronic Obstructive
- Keywords
- Lung Function Decline, Lung Function, Allergy, COPD, Vitamin D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,266 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 26 Feb 2009 (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 and chronic obstructive pulmonary disease (COPD) are diseases that affect a person's ability to breathe normally. People who do not receive enough vitamin D may have a higher risk of developing asthma or COPD. This study will examine previously collected blood samples of participants in three studies to determine whether people with low vitamin D levels have an increased risk of severe asthma or COPD.
Detailed description
Asthma and COPD are among the leading causes of illness in children and adults, respectively. Asthma is the most common long-term disease among children in the developed world, and approximately 16 million people in the United States have COPD, which is now the fourth most common cause of death in this country. Vitamin D, both a nutrient and a hormone, can be taken in through diet and exposure to sunlight. Many children and adults have a vitamin D deficiency and there is concern that current recommended intake levels may be inadequate. A vitamin D deficiency can cause immune system dysfunction and may increase the risk of developing immune-mediated disorders, such as multiple sclerosis, inflammatory bowel disease, rheumatoid arthritis, and various cancers. Because of its role in immune development and function, a vitamin D deficiency may also be related to the development of severe asthma in children and to greater lung function decline in adults, leading to COPD. Preliminary research shows that people with asthma who take vitamin D have an enhanced response to corticosteroids, a common medication used to treat asthma. This finding suggests that vitamin D could possibly be used to improve asthma treatment. The purpose of this study is to measure vitamin D levels in participants of three previous studies and determine whether lower vitamin D levels are related to the development of severe asthma or COPD.
This study will examine previously collected blood samples from participants in three studies. There will be no study visits specifically for this study. The three studies include the following:
- Childhood Asthma Management Program, which is a study that examined the use of inhaled corticosteroids, nedocromil, and placebo in children with mild-to-moderate asthma
- Genetic Epidemiology of Asthma in Costa Rica, which is an ongoing study that is identifying genetic predictors of asthma in Costa Rican families with asthma
- Normative Aging Study, which is a study of aging that is being conducted in men living in Boston
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | –All 1024 participants of the Childhood Asthma Management Program, who provided blood samples. |
| Asthma in Hispanics | – | –All 616 subjects in the Genetic Epidemiology of Asthma in Costa Rica who have serum. |
| Lung function and lung function decline | – | –626 subjects from the Normative Aging Study who have serum and lung function. |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- For the Childhood Asthma Management Program, the study population was children with mild to moderate asthma, 5 to 12 years of age, living across the United States. For the Genetic Epidemiology of Asthma in Costa Rica study, the study population was children with asthma, 5 to 12 years of age, living in Costa Rica. For the Normative Aging Study, the study population was a community sample of men living in the Boston area.
Key inclusion criteria (1 listed)
- Participated in the Childhood Asthma Management Program, the Genetic Epidemiology of Asthma in Costa Rica study, or the Normative Aging Study
Key exclusion criteria (0 listed)
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
Asthma exacerbation
Time frame: Measured at Year 4 in the original study
Lung function decline
Time frame: Measured at Year 15 in the original study
1 secondary outcome
Allergy markers
Time frame: Measured at Year 4 in the original study
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 Aug 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.
Augusto A. Litonjua, MD, MPH principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Pulmonary Disease, run by Brigham and Women's Hospital.
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 1 inclusion and 0 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 13 Aug 2012. 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?
Asthma exacerbation (time frame: Measured at Year 4 in the original study). The study lists 2 primary outcomes in all. 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 Aug 2012.