Diet and Rheumatoid Arthritis Risk in the United Kingdom Women's Cohort

October 31, 2024 updated by: Darren Greenwood, University of Leeds

The Associations Between Diet and Rheumatoid Arthritis Risk in the United Kingdom

Rheumatoid arthritis (RA) is the most common inflammatory arthritis, affecting around 1% of the UK population. It affects around 400,000 adults and is characterised by synovial inflammation, cartilage and bone damage that requires lifelong treatment and represents a significant burden for both the individual and society. Diet can affect inflammatory status and RA risk, with varying risks for women on specific diets. Low to moderate levels of alcohol consumption may be associated with lower risk of RA, and those who do not consume enough fruit and vegetables could be at a greater risk than those with adequate intakes. Our research aim is to better understand the role of diet in reducing RA risk in United Kingdom women. The research will use existing dietary and lifestyle data from the United Kingdom Women's Cohort Study and hospital records of RA incidence.

Study Overview

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

Observational

Enrollment (Actual)

35372

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS2 9JT
        • University of Leeds Leeds

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The UK Women's cohort profile is published here: https://doi.org/10.1093/ije/dyv173

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 1995

Primary Completion (Actual)

March 13, 2019

Study Completion (Actual)

March 13, 2019

Study Registration Dates

First Submitted

October 31, 2024

First Submitted That Met QC Criteria

October 31, 2024

First Posted (Estimated)

November 1, 2024

Study Record Updates

Last Update Posted (Estimated)

November 1, 2024

Last Update Submitted That Met QC Criteria

October 31, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The full data access policy for the UK Women's Cohort Study is available via the study website (https://ukwcs.leeds.ac.uk/).

IPD Sharing Time Frame

The full data access policy for the UK Women's Cohort Study is available via the study website (https://ukwcs.leeds.ac.uk/).

IPD Sharing Access Criteria

The full data access policy for the UK Women's Cohort Study is available via the study website (https://ukwcs.leeds.ac.uk/).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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