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The Effects of Nutritional on Disease Activity and Functional Status in RA

The Effects of Nutritional Status and Habits on Disease Activity, Quality of Life and Functional Status of Patients in Rheumatoid Arthritis.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05227885
Enrollment
100
Registered
2022-02-08
Start date
2021-12-20
Completion date
2022-05-31
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, nutrition, inflammation

Brief 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. 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.

Interventions

OTHERquestionnaire form

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.

Sponsors

Balikesir University
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Between the ages of 18-75, * Diagnosed with RA according to ACR 2010 diagnostic criteria, * RA disease duration at least ≥2 years

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
A questionnaire formThrough study completion, an average of 4 monthA questionnaire form to evaluate the demographic information
Nutritional status and habits;Through study completion, an average of 4 month* Nutrient consumption frequencies * 24-hour retrospective food consumption record
Functional status of the patients.Through study completion, an average of 4 monthHAQ (Health Assessment Questionnaire)
Disease activity of the patientsThrough study completion, an average of 4 monthSimple Disease Activity Index (SDAI)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026