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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05227885
• Other study ID #: BalikesirUniversty
• Status: Completed
• Start date: December 20, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: February 2023
• Source: Balikesir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 31, 2022
• Est. primary completion date: April 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• questionnaire 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.

Locations

Country	Name	City	State
Turkey	Balikesir University	Balikesir

Sponsors (1)

Lead Sponsor	Collaborator
Balikesir University

Country where clinical trial is conducted

Turkey, 

Outcome

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