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

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ClinicalTrials.gov Identifier: NCT00851695
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : August 13, 2012
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Augusto A. Litonjua, Brigham and Women's Hospital

Brief 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. 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.

Condition or disease
Asthma Pulmonary Disease Chronic Obstructive

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

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Study Type : Observational
Actual Enrollment : 2266 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Vitamin D in Obstructive Lung Diseases
Study Start Date : July 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Group/Cohort
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.



Primary Outcome Measures :
  1. Asthma exacerbation [ Time Frame: Measured at Year 4 in the original study ]
  2. Lung function decline [ Time Frame: Measured at Year 15 in the original study ]

Secondary Outcome Measures :
  1. Allergy markers [ Time Frame: Measured at Year 4 in the original study ]

Biospecimen Retention:   Samples With DNA
Serum samples


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • Participated in the Childhood Asthma Management Program, the Genetic Epidemiology of Asthma in Costa Rica study, or the Normative Aging Study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851695


Sponsors and Collaborators
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Augusto A. Litonjua, MD, MPH Brigham and Women's Hospital

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Responsible Party: Augusto A. Litonjua, Assistant Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00851695     History of Changes
Other Study ID Numbers: 1399
R21HL089842-01 ( U.S. NIH Grant/Contract )
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: August 13, 2012
Last Verified: August 2012
Keywords provided by Augusto A. Litonjua, Brigham and Women's Hospital:
Lung Function Decline
Lung Function
Allergy
COPD
Vitamin D
Additional relevant MeSH terms:
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Asthma
Lung Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents