Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006419
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-10-26
Brief Title:
Diet and Chronic Obstructive Pulmonary Disease
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 121700 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 2100 cases of confirmed COPD ie physician diagnosis and pulmonary function tests PFTs at time of diagnosis or abnormal FEV-I in past year and probable COPD ie 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 eg vitamin C vitamin E and carotenoids magnesium potassium and n-3 polyunsaturated fatty acids eg fish oils decreased risk of COPD whereas high intakes of specific fatty acids eg 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 2400 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 eg 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
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 121700 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 2100 cases of confirmed COPD ie physician diagnosis and pulmonary function tests PFTs at time of diagnosis or abnormal FEV-I in past year and probable COPD ie 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 eg vitamin C vitamin E and carotenoids magnesium potassium and n-3 polyunsaturated fatty acids eg fish oils decreased risk of COPD whereas high intakes of specific fatty acids eg 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 2400 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 eg 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL063841 | NIH | None | httpsreporternihgovquickSearchR01HL063841 |