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Examining the Role of Vitamin D in Asthma and Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT00851695

Last Updated: 2012-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2266 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-06-30

Brief Summary

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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

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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

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Asthma Pulmonary Disease Chronic Obstructive

Keywords

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Lung Function Decline Lung Function Allergy COPD Vitamin D

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Asthma

All 1024 participants of the Childhood Asthma Management Program, who provided blood samples.

No interventions assigned to this group

Asthma in Hispanics

All 616 subjects in the Genetic Epidemiology of Asthma in Costa Rica who have serum.

No interventions assigned to this group

Lung function and lung function decline

626 subjects from the Normative Aging Study who have serum and lung function.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Participated in the Childhood Asthma Management Program, the Genetic Epidemiology of Asthma in Costa Rica study, or the Normative Aging Study
Minimum Eligible Age

5 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Augusto A. Litonjua

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Augusto A. Litonjua, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Other Identifiers

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R21HL089842-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1399

Identifier Type: -

Identifier Source: org_study_id