NCT06670144

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35,372

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1995

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 1995

Completed
24.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2019

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2024

Completed
Last Updated

November 1, 2024

Status Verified

October 1, 2024

Enrollment Period

24.2 years

First QC Date

October 31, 2024

Last Update Submit

October 31, 2024

Conditions

Keywords

NutritionRheumatoid ArthritisAlcohol consumptionBody Mass IndexCohort studyEpidemiologyArthritis, Rheumatoid, Seropositive

Outcome Measures

Primary Outcomes (1)

  • Rheumatoid Arthritis incidence (first)

    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).

Study Arms (1)

United Kingdom Women's Cohort

United Kingdom Women's Cohort Study. No interventions are to be administered in this observational prospective cohort study.

Other: Dietary patternOther: Alcohol intakeOther: Fruit and vegetables intakeOther: Tea consumptionOther: Coffee consumptionOther: Fish intakeOther: Meat intakeOther: Vitamin D intake

Interventions

(regular meat-eater, occasional meat-eater, fish-eater, vegetarian, and vegan; Mediterranean diet)

United Kingdom Women's Cohort

(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.)

United Kingdom Women's Cohort

(Intake of fruits, vegetables, fruits and vegetables combined from food frequency questionnaire)

United Kingdom Women's Cohort

(Intake of tea from food frequency questionnaire)

United Kingdom Women's Cohort

(Intake of caffeinated coffee and decaffeinated coffee from food frequency questionnaire)

United Kingdom Women's Cohort

(Intake of fish from food frequency questionnaire)

United Kingdom Women's Cohort

(Intake of red meat, processed meat, and poultry from food frequency questionnaire)

United Kingdom Women's Cohort

(Estimated intake of vitamin D, derived from food frequency questionnaire and any recorded supplemental intake)

United Kingdom Women's Cohort

Eligibility Criteria

Age36 Years - 69 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Female
  • Ages 35 - 69 years at time of recruitment
  • Able to provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leeds Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

Related Publications (1)

  • Cade JE, Burley VJ, Alwan NA, Hutchinson J, Hancock N, Morris MA, Threapleton DE, Greenwood DC. Cohort Profile: The UK Women's Cohort Study (UKWCS). Int J Epidemiol. 2017 Apr 1;46(2):e11. doi: 10.1093/ije/dyv173. No abstract available.

    PMID: 26430789BACKGROUND

Related Links

MeSH Terms

Conditions

Arthritis, RheumatoidAlcohol DrinkingArthritis

Interventions

Dietary PatternsEthanolFruit

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesDrinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaFeeding BehaviorAlcoholsOrganic ChemicalsFoodFood and Beverages

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer in Biostatistics

Study Record Dates

First Submitted

October 31, 2024

First Posted

November 1, 2024

Study Start

January 15, 1995

Primary Completion

March 13, 2019

Study Completion

March 13, 2019

Last Updated

November 1, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF
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/).
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/).
More information

Locations