Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Diet and Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00006419
First received: October 26, 2000
Last updated: June 23, 2005
Last verified: May 2005
  Purpose

To examine the relationship of specific dietary factors to risk of chronic obstructive pulmonary disease.


Condition
Lung Diseases, Obstructive
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Natural History

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: July 2000
Estimated Study Completion Date: June 2004
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006419

Sponsors and Collaborators
Investigators
Investigator: Carlos Camargo Brigham and Women's Hospital
  More Information