Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005385
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Seasonal Variation of Blood Cholesterol Levels
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:
2005-10
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 describe and delineate in a prospective study the nature and causes of seasonal variation of blood lipid levels in the general population
Detailed Description:
BACKGROUND
Significant seasonal variation of blood cholesterol levels has been shown in a number of cross-sectional studies with important implications for national screening and therapeutic guidelines However the phenomenon has not been well studied little is known about etiology or about seasonal variation of lipid subfractions
DESIGN NARRATIVE
The investigators assessed the magnitude and timing of the seasonal effect for total cholesterol and the important lipoprotein subfractions low-density lipoprotein high-density lipoprotein triglycerides apolipoproteins AI and B and lipoprotein a in both sexes and at different ages They also identified and quantified the effects of the main factors determining the variation and assessed the seasonal variation of other blood elements thought to play a role in the development of coronary heart disease including hemostatic factors and antioxidants Finally they explored the implications of the phenomenon for public health policy
Baseline and serial measures were repeated quarterly for one year These included measures of serum lipids and lipoproteins antioxidant vitamins platelets and hemostatic factors demographic factors weight waist-hip ratio height body mass index BMI and blood pressure dietary intake physical activity light exposure and psychologic factors Meteorologic data were also collected Data were collected by written questionnaire and by the use of computer-assisted evening telephone interviews CATI which were used for the collection of dietary physical activity and individual light-exposure and other lifestyle data Activity and light data were verified in a subset of 80 patients by the use of a monitoring device Analyses included methods to describe the seasonal variation in dietary physical activity psychologic and light exposure data and repeated measures in linear regression models to determine the roles of specific dietary physical activity psychologic and light-exposure related covariates in explaining variability in blood lipids antioxidant vitamins and hemostatic factors
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Significant seasonal variation of blood cholesterol levels has been shown in a number of cross-sectional studies with important implications for national screening and therapeutic guidelines However the phenomenon has not been well studied little is known about etiology or about seasonal variation of lipid subfractions
DESIGN NARRATIVE
The investigators assessed the magnitude and timing of the seasonal effect for total cholesterol and the important lipoprotein subfractions low-density lipoprotein high-density lipoprotein triglycerides apolipoproteins AI and B and lipoprotein a in both sexes and at different ages They also identified and quantified the effects of the main factors determining the variation and assessed the seasonal variation of other blood elements thought to play a role in the development of coronary heart disease including hemostatic factors and antioxidants Finally they explored the implications of the phenomenon for public health policy
Baseline and serial measures were repeated quarterly for one year These included measures of serum lipids and lipoproteins antioxidant vitamins platelets and hemostatic factors demographic factors weight waist-hip ratio height body mass index BMI and blood pressure dietary intake physical activity light exposure and psychologic factors Meteorologic data were also collected Data were collected by written questionnaire and by the use of computer-assisted evening telephone interviews CATI which were used for the collection of dietary physical activity and individual light-exposure and other lifestyle data Activity and light data were verified in a subset of 80 patients by the use of a monitoring device Analyses included methods to describe the seasonal variation in dietary physical activity psychologic and light exposure data and repeated measures in linear regression models to determine the roles of specific dietary physical activity psychologic and light-exposure related covariates in explaining variability in blood lipids antioxidant vitamins and hemostatic factors
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 |
|---|---|---|---|
| R01HL052745 | NIH | None | httpsreporternihgovquickSearchR01HL052745 |