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Lung Diseases, ObstructiveNCT00006419

Diet and Chronic Obstructive Pulmonary Disease

An observational study of Lung Diseases, Obstructive and Chronic Obstructive Pulmonary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To examine the relationship of specific dietary factors to risk of chronic obstructive pulmonary disease. Read more about this study

Who is it for?
Ages Up to 100 years, women only
How many people
Not given
Where
No sites listed yet
Study dates
Jul 2000to Jun 2004
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 100 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

No eligibility criteria

About this study

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

Read the 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.

Medical subject headings
Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2000 (estimated)
  2. Study startJul 2000
  3. Study completionJun 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006419
Sponsor's protocol ID
935
Other IDs
R01HL063841
Status last verified
May 2005
First submitted
26 Oct 2000
Last updated
16 Mar 2016
Results posted
No

Publications

  • 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.

    PubMed 12153380
  • 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.

    PubMed 14599730
  • 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.

    PubMed 15451919
  • 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.

    PubMed 14980988
  • 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.

    PubMed 15888831

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Diseases, Obstructive and Chronic Obstructive Pulmonary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006419, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.

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