Rheumatoid Arthritis (RA)NCT06670144
Diet and Rheumatoid Arthritis Risk in the United Kingdom Women's Cohort
An observational study of Rheumatoid Arthritis (RA), run by University of Leeds at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 36 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Dietary pattern, Alcohol intake and Fruit and vegetables intake
- How many people
- 35,372 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 1995to 13 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The UK Women's cohort profile is published here: https://doi.org/10.1093/ije/dyv173
Who may be able to join
- Female
- Ages 35 - 69 years at time of recruitment
- Able to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leeds Leeds
Leeds, West Yorkshire, LS2 9JT
About this study
Official title: 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.
Read the 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.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Dietary pattern, Alcohol intake, Fruit and vegetables intake, Tea consumption, Coffee consumption
- Keywords
- Nutrition, Rheumatoid Arthritis, Alcohol consumption, Body Mass Index, Cohort study, Epidemiology, Arthritis, Rheumatoid, Seropositive
- Medical subject headings
- Arthritis, Rheumatoid, Alcohol Drinking, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary patternOther
(regular meat-eater, occasional meat-eater, fish-eater, vegetarian, and vegan; Mediterranean diet)
Alcohol intakeOther
(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 intakeOther
(Intake of fruits, vegetables, fruits and vegetables combined from food frequency questionnaire)
Tea consumptionOther
(Intake of tea from food frequency questionnaire)
Coffee consumptionOther
(Intake of caffeinated coffee and decaffeinated coffee from food frequency questionnaire)
Fish intakeOther
(Intake of fish from food frequency questionnaire)
Meat intakeOther
(Intake of red meat, processed meat, and poultry from food frequency questionnaire)
Vitamin D intakeOther
(Estimated intake of vitamin D, derived from food frequency questionnaire and any recorded supplemental intake)
| Study group | Role | What they receive |
|---|---|---|
| United Kingdom Women's Cohort | United Kingdom Women's Cohort Study. No interventions are to be administered in this observational prospective cohort study. Receives: Other: Dietary pattern; Other: Alcohol intake; Other: Fruit and vegetables intake; Other: Tea consumption; Other: Coffee consumption; Other: Fish intake; Other: Meat intake; Other: Vitamin D intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rheumatoid Arthritis incidence (first)
Incidence of first rheumatoid arthritis ascertained from linkage to Hospital Episode Statistics (HES) data.
Measured: Time Frame: age when the completed questionnaire was returned (1995-1998) until age at event, death, or end of study period (19 Mar 2019).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start15 Jan 1995
- Primary completion13 Mar 2019
- Study completion13 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35,372 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darren Greenwood, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670144
- Sponsor's protocol ID
- fsydo_UKWCS
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full data access policy for the UK Women's Cohort Study is available via the study website (https://ukwcs.leeds.ac.uk/).
Publications
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.
PubMed 26430789
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Associations Between Diet and Rheumatoid Arthritis Risk in the United Kingdom
- ClinicalTrials.gov ID
- NCT06670144
- Acronym / sponsor ID
- fsydo_UKWCS
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Nutrition, Rheumatoid Arthritis, Alcohol consumption, Body Mass Index, Cohort study, Epidemiology, Arthritis, Rheumatoid, Seropositive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35,372 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 15 Jan 1995 (actual)
- Primary completion
- 13 Mar 2019 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| United Kingdom Women's Cohort | – | Other: Dietary pattern, Other: Alcohol intake, Other: Fruit and vegetables intake, Other: Tea consumption, Other: Coffee consumption, Other: Fish intake, Other: Meat intake, Other: Vitamin D intakeUnited Kingdom Women's Cohort Study. No interventions are to be administered in this observational prospective cohort study. |
Who may qualify
- Ages
- 36 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The UK Women's cohort profile is published here: https://doi.org/10.1093/ije/dyv173
Key inclusion criteria (3 listed)
- Female
- Ages 35 - 69 years at time of recruitment
- Able to provide informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary pattern(regular meat-eater, occasional meat-eater, fish-eater, vegetarian, and vegan; Mediterranean diet) | Other | United Kingdom Women's Cohort |
| 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.) | Other | United Kingdom Women's Cohort |
| Fruit and vegetables intake(Intake of fruits, vegetables, fruits and vegetables combined from food frequency questionnaire) | Other | United Kingdom Women's Cohort |
| Tea consumption(Intake of tea from food frequency questionnaire) | Other | United Kingdom Women's Cohort |
| Coffee consumption(Intake of caffeinated coffee and decaffeinated coffee from food frequency questionnaire) | Other | United Kingdom Women's Cohort |
| Fish intake(Intake of fish from food frequency questionnaire) | Other | United Kingdom Women's Cohort |
| Meat intake(Intake of red meat, processed meat, and poultry from food frequency questionnaire) | Other | United Kingdom Women's Cohort |
| Vitamin D intake(Estimated intake of vitamin D, derived from food frequency questionnaire and any recorded supplemental intake) | Other | United Kingdom Women's Cohort |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Background: PubMed 26430789Cade 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.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The full data access policy for the UK Women's Cohort Study is available via the study website (https://ukwcs.leeds.ac.uk/).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis (RA), run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06670144, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.