Diet and Chronic Obstructive Pulmonary Disease
Primary Purpose
Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Lung Diseases, Obstructive
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006419
First Posted
October 26, 2000
Last Updated
March 15, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00006419
Brief Title
Diet and Chronic Obstructive Pulmonary Disease
Study Type
Observational
2. Study Status
Record Verification Date
May 2005
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To examine the relationship of specific dietary factors to risk of chronic obstructive pulmonary disease.
Detailed Description
BACKGROUND:
Although tobacco smoking is the major environmental risk factor for COPD, only a minority of smokers develops this condition, and it appears that genetic and other environmental factors are important in determining risk. There has been growing interest in the hypothesis that dietary factors modify COPD risk, possibly by protecting against oxidant injury. Available data addressing this hypothesis have a variety of methodological limitations that preclude any firm conclusions. The study was the first to address this hypothesis using data from the Nurses' Health Study, a large, prospective cohort study with detailed dietary assessments and a follow-up interval of sufficient duration to examine incident COPD.
DESIGN NARRATIVE:
The study examined the relationship between dietary factors and chronic obstructive pulmonary disease (COPD) among participants in the Nurses' Health Study, an ongoing prospective cohort study of 121,700 women, ages 39-64 in 1985. This cohort had been followed by means of biennial questionnaires which inquired about a variety of topics, including dietary intake (using a validated semi-quantitative food frequency questionnaire) and physician diagnosis of COPD. In 1998, all participants with a history of COPD were sent a supplementary questionnaire regarding specifics of COPD diagnosis and related topics. The study examined the relation of dietary factors to risk of newly-diagnosed COPD during 1985-1998. During this time period, there were approximately 2,100 cases of "confirmed" COPD (i.e., physician diagnosis and pulmonary function tests [PFTs] at time of diagnosis or abnormal FEV-I in past year) and "probable" COPD (i.e., physician diagnosis and recent respiratory symptoms, but PFTs not known). Preliminary data supported the validity of these case definitions, and this was examined further by reviewing 600 medical records. Likewise, potential under-diagnosis was examined in a random sample of past and current smokers who had never reported COPD or asthma. The specific dietary hypotheses were that high intakes of antioxidants (e.g., vitamin C, vitamin E, and carotenoids), magnesium, potassium, and n-3 polyunsaturated fatty acids (e.g., fish oils) decreased risk of COPD, whereas high intakes of specific fatty acids (e.g., linoieic acid) increased risk. The cohort size and 13-year follow-up provided >90 percent power to detect a trend across quintiles of dietary intake. In 1998, among approximately 2,400 prevalent cases with diet data, study investigators addressed a secondary aim: to determine the relation of dietary factors to COPD severity during 1998-2000. COPD severity was assessed by self-report of current medications, recent symptoms, activity limitations, and health care utilization (e.g., emergency room or urgent office visits for COPD exacerbations). The rising prevalence of COPD, particularly among women, along with its high societal cost, makes COPD prevention an important public health goal.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
7. Study Design
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Camargo
Organizational Affiliation
Brigham and Women's Hospital
12. IPD Sharing Statement
Citations:
PubMed Identifier
12153380
Citation
Barr RG, Somers SC, Speizer FE, Camargo CA Jr; National Asthma Education and Prevention Program (NAEPP). Patient factors and medication guideline adherence among older women with asthma. Arch Intern Med. 2002 Aug 12-26;162(15):1761-8. doi: 10.1001/archinte.162.15.1761.
Results Reference
background
PubMed Identifier
14599730
Citation
Kim S, Camargo CA Jr. Sex-race differences in the relationship between obesity and asthma: the behavioral risk factor surveillance system, 2000. Ann Epidemiol. 2003 Nov;13(10):666-73. doi: 10.1016/s1047-2797(03)00054-1.
Results Reference
background
PubMed Identifier
15451919
Citation
Rana JS, Mittleman MA, Sheikh J, Hu FB, Manson JE, Colditz GA, Speizer FE, Barr RG, Camargo CA Jr. Chronic obstructive pulmonary disease, asthma, and risk of type 2 diabetes in women. Diabetes Care. 2004 Oct;27(10):2478-84. doi: 10.2337/diacare.27.10.2478.
Results Reference
background
PubMed Identifier
14980988
Citation
Barr RG, Wentowski CC, Grodstein F, Somers SC, Stampfer MJ, Schwartz J, Speizer FE, Camargo CA Jr. Prospective study of postmenopausal hormone use and newly diagnosed asthma and chronic obstructive pulmonary disease. Arch Intern Med. 2004 Feb 23;164(4):379-86. doi: 10.1001/archinte.164.4.379.
Results Reference
background
PubMed Identifier
15888831
Citation
Griswold SK, Nordstrom CR, Clark S, Gaeta TJ, Price ML, Camargo CA Jr. Asthma exacerbations in North American adults: who are the "frequent fliers" in the emergency department? Chest. 2005 May;127(5):1579-86. doi: 10.1378/chest.127.5.1579.
Results Reference
background
Learn more about this trial
Diet and Chronic Obstructive Pulmonary Disease
We'll reach out to this number within 24 hrs