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

February 7, 2023 updated by: Bilal Uysal, Balikesir University

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Balıkesir, Turkey, 10145
        • Balikesir University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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,

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Balikesir University

Investigators

  • Principal Investigator: Bilal UYSAL, MD, Balikesir University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 20, 2021

Primary Completion (ACTUAL)

April 29, 2022

Study Completion (ACTUAL)

May 31, 2022

Study Registration Dates

First Submitted

January 6, 2022

First Submitted That Met QC Criteria

January 22, 2022

First Posted (ACTUAL)

February 8, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BalikesirUniversty

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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