Rheumatoid ArthritisNCT05227885
The Effects of Nutritional on Disease Activity and Functional Status in RA
An observational study of Rheumatoid Arthritis, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial summary
Rheumatoid arthritis (RA) is a chronic, autoimmune, systemic, inflammatory disease. RA is a chronic inflammatory disease in which many patients cannot achieve remission despite current pharmacological treatments. Chronic inflammation in RA causes an increase in metabolic index and nutritional requirements. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- questionnaire form
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2021to 31 May 2022
- How long will I take part?
- 6 Months
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-75 years, with a disease duration of at least 2 years or more, diagnosed with RA according to ACR 2010 diagnostic criteria,
Who may be able to join
- Between the ages of 18-75,
- Diagnosed with RA according to ACR 2010 diagnostic criteria,
- RA disease duration at least ≥2 years
Who cannot join
- Pregnant
- During the lactation period,
- Malignancy
- Using more than 10 mg of prednisolone per day,
- The period after the diagnosis of Ra is ≤2 years,
- Changes in medical treatment, DMARD and/or biological agent use in the last 8 weeks,
- Patients who cannot understand the information in the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Nutritional Status and Habits on Disease Activity, Quality of Life and Functional Status of Patients in Rheumatoid Arthritis.
Rheumatoid arthritis (RA) is a chronic, autoimmune, systemic, inflammatory disease.
RA is a chronic inflammatory disease in which many patients cannot achieve remission despite current pharmacological treatments. Chronic inflammation in RA causes an increase in metabolic index and nutritional requirements. In recent studies, it is mentioned that diet regimens and foods consumed in nutrition affect inflammation.
Read more
The aim of this study is to evaluate the nutritional status and habits of patients with RA and to examine their effects on disease activity level, quality of life and functional status.
A questionnaire form will be applied to collect data on demographic information, disease activity, nutritional status and habits, physical activity status and physical functional status of the patients included in the study.
Read the detailed description
Rheumatoid arthritis (RA) is a chronic, autoimmune, systemic, inflammatory disease affecting 0.5-1.0% of the population. RA is a chronic inflammatory disease in which many patients cannot achieve remission despite current pharmacological treatments. Chronic inflammation in RA causes an increase in metabolic index and nutritional requirements. In recent studies, it is mentioned that diet regimens and foods consumed in nutrition affect inflammation.
The aim of this study is to evaluate the nutritional status and habits of patients with RA and to examine their effects on disease activity level, quality of life and functional status.
This study will be conducted with 100 patients diagnosed with RA in Balıkesir University, Health Practice and Research Hospital, Department of Physical Medicine and Rehabilitation outpatient clinic.
Patients between the ages of 18-75, diagnosed with RA according to the ACR 2010 diagnostic criteria, with a disease duration of 2 or more, using less than 10 mg of prednisolone per day, will be included in the study. Patients with a duration of ≤2 years after the diagnosis of RA, a change in the use of DMARDs and/or biological agents in their medical treatment for the last 8 weeks, using prednisolone more than 10 mg daily, malignancy, pregnant, lactating, and those who cannot understand the information in the questionnaire was not included in the study.
A questionnaire form will be applied to collect data on demographic information, disease activity, nutritional status and habits, physical activity and physical functional status of the patients included in the study.
As a result of this study, it is aimed to help patients with rheumatoid arthritis reach remission with diet programs and recommendations in addition to existing drug treatments.
- Conditions
- Rheumatoid Arthritis
- Being tested
- questionnaire form
- Keywords
- Rheumatoid Arthritis, nutrition, inflammation
- Medical subject headings
- Arthritis, Rheumatoid, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire formOther
A questionnaire will be applied to all participants. A questionnaire form will be applied to collect data on demographic information, pain, disease activity, nutritional habits, physical activity status and physical functional status of the patients included in the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
A questionnaire form
A questionnaire form to evaluate the demographic information
Measured: Through study completion, an average of 4 month
Nutritional status and habits;
- Nutrient consumption frequencies
- 24-hour retrospective food consumption record
Measured: Through study completion, an average of 4 month
Functional status of the patients.
HAQ (Health Assessment Questionnaire)
Measured: Through study completion, an average of 4 month
Disease activity of the patients
Simple Disease Activity Index (SDAI)
Measured: Through study completion, an average of 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start20 Dec 2021
- Primary completion29 Apr 2022
- Study completion31 May 2022
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.
- 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilal Uysal, Balikesir University
- Investigators
- Bilal UYSAL, MD, Principal investigator, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227885
- Sponsor's protocol ID
- BalikesirUniversty
- Status last verified
- Feb 2023
- First submitted
- 6 Jan 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Nutritional Status and Habits on Disease Activity, Quality of Life and Functional Status of Patients in Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT05227885
- Acronym / sponsor ID
- BalikesirUniversty
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, nutrition, inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 8 Feb 2022 (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 a chronic, autoimmune, systemic, inflammatory disease.
RA is a chronic inflammatory disease in which many patients cannot achieve remission despite current pharmacological treatments. Chronic inflammation in RA causes an increase in metabolic index and nutritional requirements. In recent studies, it is mentioned that diet regimens and foods consumed in nutrition affect inflammation.
The aim of this study is to evaluate the nutritional status and habits of patients with RA and to examine their effects on disease activity level, quality of life and functional status.
A questionnaire form will be applied to collect data on demographic information, disease activity, nutritional status and habits, physical activity status and physical functional status of the patients included in the study.
Detailed description
Rheumatoid arthritis (RA) is a chronic, autoimmune, systemic, inflammatory disease affecting 0.5-1.0% of the population. RA is a chronic inflammatory disease in which many patients cannot achieve remission despite current pharmacological treatments. Chronic inflammation in RA causes an increase in metabolic index and nutritional requirements. In recent studies, it is mentioned that diet regimens and foods consumed in nutrition affect inflammation.
The aim of this study is to evaluate the nutritional status and habits of patients with RA and to examine their effects on disease activity level, quality of life and functional status.
This study will be conducted with 100 patients diagnosed with RA in Balıkesir University, Health Practice and Research Hospital, Department of Physical Medicine and Rehabilitation outpatient clinic.
Patients between the ages of 18-75, diagnosed with RA according to the ACR 2010 diagnostic criteria, with a disease duration of 2 or more, using less than 10 mg of prednisolone per day, will be included in the study. Patients with a duration of ≤2 years after the diagnosis of RA, a change in the use of DMARDs and/or biological agents in their medical treatment for the last 8 weeks, using prednisolone more than 10 mg daily, malignancy, pregnant, lactating, and those who cannot understand the information in the questionnaire was not included in the study.
A questionnaire form will be applied to collect data on demographic information, disease activity, nutritional status and habits, physical activity and physical functional status of the patients included in the study.
As a result of this study, it is aimed to help patients with rheumatoid arthritis reach remission with diet programs and recommendations in addition to existing drug treatments.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-75 years, with a disease duration of at least 2 years or more, diagnosed with RA according to ACR 2010 diagnostic criteria,
Key inclusion criteria (3 listed)
- Between the ages of 18-75,
- Diagnosed with RA according to ACR 2010 diagnostic criteria,
- RA disease duration at least ≥2 years
Key exclusion criteria (7 listed)
- Pregnant
- During the lactation period,
- Malignancy
- Using more than 10 mg of prednisolone per day,
- The period after the diagnosis of Ra is ≤2 years,
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 |
|---|---|---|
| questionnaire formA questionnaire will be applied to all participants. A questionnaire form will be applied to collect data on demographic information, pain, disease activity, nutritional habits, physical activity status and physical functional status of the patients included in the study. | Other | – |
Primary outcome
A questionnaire form
Time frame: Through study completion, an average of 4 month
A questionnaire form to evaluate the demographic information
Nutritional status and habits;
Time frame: Through study completion, an average of 4 month
* Nutrient consumption frequencies * 24-hour retrospective food consumption record
Functional status of the patients.
Time frame: Through study completion, an average of 4 month
HAQ (Health Assessment Questionnaire)
Disease activity of the patients
Time frame: Through study completion, an average of 4 month
Simple Disease Activity Index (SDAI)
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 8 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
Bilal UYSAL, MD principal investigator
Balikesir University
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, run by Balikesir University at 1 site in Turkey (Türkiye).
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 7 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 8 Feb 2023. 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 Turkey (Türkiye). 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?
A questionnaire form (time frame: Through study completion, an average of 4 month). The study lists 4 primary outcomes in all. 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 8 Feb 2023.