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

NCT ID: NCT06670144

Last Updated: 2024-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35372 participants

Study Classification

OBSERVATIONAL

Study Start Date

1995-01-15

Study Completion Date

2019-03-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis (RA)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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United Kingdom Women's Cohort

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

Dietary pattern

Intervention Type OTHER

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

Alcohol intake

Intervention Type OTHER

(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.)

Fruit and vegetables intake

Intervention Type OTHER

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

Tea consumption

Intervention Type OTHER

(Intake of tea from food frequency questionnaire)

Coffee consumption

Intervention Type OTHER

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

Fish intake

Intervention Type OTHER

(Intake of fish from food frequency questionnaire)

Meat intake

Intervention Type OTHER

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

Vitamin D intake

Intervention Type OTHER

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

Interventions

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Dietary pattern

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

Intervention Type OTHER

Alcohol intake

(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.)

Intervention Type OTHER

Fruit and vegetables intake

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

Intervention Type OTHER

Tea consumption

(Intake of tea from food frequency questionnaire)

Intervention Type OTHER

Coffee consumption

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

Intervention Type OTHER

Fish intake

(Intake of fish from food frequency questionnaire)

Intervention Type OTHER

Meat intake

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

Intervention Type OTHER

Vitamin D intake

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

36 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Leeds

OTHER

Sponsor Role lead

Responsible Party

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Darren Greenwood

Senior Lecturer in Biostatistics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Leeds Leeds

Leeds, West Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 26430789 (View on PubMed)

Related Links

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Other Identifiers

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fsydo_UKWCS

Identifier Type: -

Identifier Source: org_study_id

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