NCT00851695

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,266

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2007

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

August 13, 2012

Status Verified

August 1, 2012

Enrollment Period

2.9 years

First QC Date

February 20, 2009

Last Update Submit

August 10, 2012

Conditions

Keywords

Lung Function DeclineLung FunctionAllergyCOPDVitamin D

Outcome Measures

Primary Outcomes (2)

  • Asthma exacerbation

    Measured at Year 4 in the original study

  • Lung function decline

    Measured at Year 15 in the original study

Secondary Outcomes (1)

  • Allergy markers

    Measured at Year 4 in the original study

Study Arms (3)

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.

Eligibility Criteria

Age5 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples

MeSH Terms

Conditions

AsthmaLung DiseasesHypersensitivityPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityHypersensitivity, ImmediateImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Augusto A. Litonjua, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 20, 2009

First Posted

February 26, 2009

Study Start

July 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

August 13, 2012

Record last verified: 2012-08