Rheumatoid ArthritisRHUMADIETNCT03770884
Rheumatism and Dietetic: RHUMADIET Study (Food Practices and Beliefs)
An observational study of Rheumatoid Arthritis and Axial Spondyloarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Cross sectional study assessing food practices and beliefs in RA, AS and DA (digital arthritis) Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Axial Spondyloarthritis, Hand Osteoarthritis
- How many people
- 448 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2019to 18 Apr 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: RA (EULAR/ACR criteria) AS (ASAS criteria ) DA (ACR criteria)
Who may be able to join
- Over 18 years of age
- Rheumatoid arthritis (RA) according to ACR/EULAR criteria or axial spondyloarthritis (AS) according to ASAS 2009 criteria or digital osteoarthritis (DA) according to ACR criteria.
Who cannot join
- Severe upper functional or psychiatric disorders
- Patients under guardianship or trusteeship
- Patients unable to answer the questionnaire in French
Trial locations and contacts
1 site in 1 country.
About this study
Cross sectional study assessing food practices and beliefs in RA, AS and DA (digital arthritis)
Read the detailed description
To investigate in patients having rheumatoid arthritis (RA), or axial spondyloarthritis (AS) or digital osteoarthritis (DA) practices and beliefs about influence of food and diet on their rheumatic disease.
200 patients of each disease will be included in this cross-sectional non interventional study Factors associated with specific practices or specific beliefs will be determined.
Only questionnaires are used in this study.
- Keywords
- rheumatoid arthritis, Axial spondyloarthritis, hand osteoarthritis, diet, beliefs
- Medical subject headings
- Arthritis, Rheumatoid, Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis | EULAR-ACR criteria Whatever the treatment and the disease activity | |
| Axial spondyloarthritis | ASAS criteria for axial disease Whatever the treatment and the disease activity | |
| digital osteoarthritis | According to ACR criteria Whatever the treatment and the disease activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who follow or have followed at least one diet for their rheumatic disease among gluten-free, cow's milk, lactose-free, vegetarian, vegan, Seignalet, Mediterranean, fasting period
Binary criterion: Diet follower Yes/No
Measured: 10 minutes
Secondary outcomes (7)
comparison between each rheumatism rheumatoid arthritis, Axial spondyloarthritis digital osteoarthritis of the prevalence of patients having followed or following one or more diets
Proportion of diet follower patients in RA versus AS versus DA. Specific food and diet questionnaires will be used in this study.
Measured: 10 minutes
For each type of food, prevalence of patients with RA considering that the food influences the rheumatic pain in each rheumatic disease
for each type of food (meat, vegetables, fruits, grains, nuts, fish, alcohol, soda), prevalence of patients with RA considering that food influence their disease symptoms
Measured: 10 minutes
For each type of food, prevalence of patients with AS considering that the food influences the rheumatic pain in each rheumatic disease
for each type of food (meat, vegetables, fruits, grains, nuts, fish, alcohol, soda), prevalence of patients with AS considering that food influence their disease symptoms
Measured: 10 minutes
For each type of food, prevalence of patients with DA considering that the food influences the rheumatic pain in each rheumatic disease
for each type of food (meat, vegetables, fruits, grains, nuts, fish, alcohol, soda), prevalence of patients with DA considering that food influence their disease symptoms
Measured: 10 minutes
Research of socio-demographic or rheumatic factors associated with dieting in RA.
In RA population:Unajusted and adjusted risk of diet (odds ratio) assiociated with the following factors reported from patient file or patient questionnaires.
- Sociodemorgraphic parameters:Age, gender, education level.
- Physiologic parameters: Autoantibody status, BMI
- Clinical parameters: treatments, disease activity using DAS 28 scale.
Measured: 10 minutes
Research of socio-demographic or rheumatic factors associated with dieting in AS.
In AS population: Unajusted and adjusted risk of diet (odds ratio) assiociated with the following factors reported from patient file or patient questionnaires.
- Sociodemorgraphic parameters:Age, gender, education level.
- Physiologic parameters: BMI
- Clinical parameters: treatments, disease activity using BASDAI Scale
Measured: 10 minutes
Research of socio-demographic or rheumatic factors associated with dieting in DA.
In DA population: Unajusted and adjusted risk of diet (odds ratio) assiociated with the following factors reported from patient file or patient questionnaires.
- Sociodemorgraphic parameters: Age, gender, education level.
- Physiologic parameters: BMI
- Clinical parameters: treatments, disease activity using 0-100mm visual analogic scale
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start8 Jan 2019
- Primary completion18 Apr 2019
- Study completion18 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérémie SELLAM, Prof,MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770884
- Sponsor's protocol ID
- NI18027J
- Other IDs
- 2018-A01340-55, HAO18041
- Acronym
- RHUMADIET
- Status last verified
- Jul 2021
- First submitted
- 9 Jul 2018
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rheumatism and Dietetic: RHUMADIET Study (Food Practices and Beliefs)
- ClinicalTrials.gov ID
- NCT03770884
- Acronym / sponsor ID
- RHUMADIET / NI18027J
- Keywords
- rheumatoid arthritis, Axial spondyloarthritis, hand osteoarthritis, diet, beliefs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 18 Apr 2019 (actual)
- Study completion
- 18 Apr 2019 (actual)
- First posted
- 10 Dec 2018 (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.
Cross sectional study assessing food practices and beliefs in RA, AS and DA (digital arthritis)
Detailed description
To investigate in patients having rheumatoid arthritis (RA), or axial spondyloarthritis (AS) or digital osteoarthritis (DA) practices and beliefs about influence of food and diet on their rheumatic disease.
200 patients of each disease will be included in this cross-sectional non interventional study Factors associated with specific practices or specific beliefs will be determined.
Only questionnaires are used in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis | – | –EULAR-ACR criteria Whatever the treatment and the disease activity |
| Axial spondyloarthritis | – | –ASAS criteria for axial disease Whatever the treatment and the disease activity |
| digital osteoarthritis | – | –According to ACR criteria Whatever the treatment and the disease activity |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RA (EULAR/ACR criteria) AS (ASAS criteria ) DA (ACR criteria)
Key inclusion criteria (2 listed)
- Over 18 years of age
- Rheumatoid arthritis (RA) according to ACR/EULAR criteria or axial spondyloarthritis (AS) according to ASAS 2009 criteria or digital osteoarthritis (DA) according to ACR criteria.
Key exclusion criteria (3 listed)
- Severe upper functional or psychiatric disorders
- Patients under guardianship or trusteeship
- Patients unable to answer the questionnaire in French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients who follow or have followed at least one diet for their rheumatic disease among gluten-free, cow's milk, lactose-free, vegetarian, vegan, Seignalet, Mediterranean, fasting period
Time frame: 10 minutes
Binary criterion: Diet follower Yes/No
7 secondary outcomes
comparison between each rheumatism rheumatoid arthritis, Axial spondyloarthritis digital osteoarthritis of the prevalence of patients having followed or following one or more diets
Time frame: 10 minutes
For each type of food, prevalence of patients with RA considering that the food influences the rheumatic pain in each rheumatic disease
Time frame: 10 minutes
For each type of food, prevalence of patients with AS considering that the food influences the rheumatic pain in each rheumatic disease
Time frame: 10 minutes
For each type of food, prevalence of patients with DA considering that the food influences the rheumatic pain in each rheumatic disease
Time frame: 10 minutes
Research of socio-demographic or rheumatic factors associated with dieting in RA.
Time frame: 10 minutes
Research of socio-demographic or rheumatic factors associated with dieting in AS.
Time frame: 10 minutes
Research of socio-demographic or rheumatic factors associated with dieting in DA.
Time frame: 10 minutes
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 3 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Jérémie SELLAM, Prof,MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 and Axial Spondyloarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 inclusion and 3 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 3 Aug 2021. 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 France. 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?
Proportion of patients who follow or have followed at least one diet for their rheumatic disease among gluten-free, cow's milk, lactose-free, vegetarian, vegan, Seignalet, Mediterranean, fasting period (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2021.