- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06670144
Diet and Rheumatoid Arthritis Risk in the United Kingdom Women's Cohort
The Associations Between Diet and Rheumatoid Arthritis Risk in the United Kingdom
Study Overview
Status
Conditions
Detailed Description
Background: Rheumatoid arthritis (RA) is a typical inflammatory arthritic disease that increases morbidity and mortality of cardiovascular diseases worldwide. Previous observational studies have shown potential for risk reduction through dietary factors modification, but associations between most of dietary factors and RA incidence are still uncertain, and evidence in United Kingdom populations is limited. Therefore, this study aims to assess associations between diet and RA incidence in the United Kingdom Women's Cohort.
Research plan and methods: The dietary and lifestyle data from the United Kingdom Women's Cohort, which recruited 35,372 middle-aged women between 1995-1998, will be used. These data were linked to Hospital Episode Statistics to provide data on the incidence of RA in participants.
Cox regression models will be applied to explore potential associations between dietary factors and RA incidence. Dietary factors will be modelled both as categorical and continuous variables so that models can be fit comparing the risk of RA between categories of intakes and per increment increase in exposure intake (linear dose-response). Restricted cubic splines will be used to model non-linear associations for dietary intake of alcohol, fruits, vegetables, tea, and coffee, since previous research has suggested possible non-linear associations for these variables.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
West Yorkshire
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Leeds, West Yorkshire, United Kingdom, LS2 9JT
- University of Leeds Leeds
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female
- Ages 35 - 69 years at time of recruitment
- Able to provide informed consent
Exclusion Criteria:
- Male
- Not a resident of England
- Unable to link dietary and lifestyle data with hospital episode data
- Missing covariate data
- Rheumatoid arthritis records before or on the date of recruitment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
United Kingdom Women's Cohort
United Kingdom Women's Cohort Study.
No interventions are to be administered in this observational prospective cohort study.
|
(regular meat-eater, occasional meat-eater, fish-eater, vegetarian, and vegan; Mediterranean diet)
(Frequency and intake of beer, wine, sherry, and spirits were collected by asking the number of specified units (pints, glasses or measures) of each type of alcoholic beverage (beer or cider, wine, sherry or fortified wines, and spirits) per week.)
(Intake of fruits, vegetables, fruits and vegetables combined from food frequency questionnaire)
(Intake of tea from food frequency questionnaire)
(Intake of caffeinated coffee and decaffeinated coffee from food frequency questionnaire)
(Intake of fish from food frequency questionnaire)
(Intake of red meat, processed meat, and poultry from food frequency questionnaire)
(Estimated intake of vitamin D, derived from food frequency questionnaire and any recorded supplemental intake)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rheumatoid Arthritis incidence (first)
Time Frame: Time Frame: age when the completed questionnaire was returned (1995-1998) until age at event, death, or end of study period (19 Mar 2019).
|
Incidence of first rheumatoid arthritis ascertained from linkage to Hospital Episode Statistics (HES) data.
|
Time Frame: age when the completed questionnaire was returned (1995-1998) until age at event, death, or end of study period (19 Mar 2019).
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- fsydo_UKWCS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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