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

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT05227885
• Lead Sponsor: Balikesir University

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.

Study Timeline

• Study Start: 2021-12-20
• Study First Submitted: 2022-01-06
• Study First Submitted QC: 2022-01-22
• Study First Posted: 2022-02-08
• Primary Completion: 2022-04-29
• Study Completion: 2022-05-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A questionnaire form	Through study completion, an average of 4 month	A questionnaire form to evaluate the demographic information
Functional status of the patients.	Through study completion, an average of 4 month	HAQ (Health Assessment Questionnaire)
Disease activity of the patients	Through study completion, an average of 4 month	Simple Disease Activity Index (SDAI)
Nutritional status and habits;	Through study completion, an average of 4 month	* Nutrient consumption frequencies; * 24-hour retrospective food consumption record

Trial Locations

Locations (1)

Balikesir University; 🇹🇷 Balıkesir, Turkey