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

NCT05227885 | Completed

• 1 other identifier: BalikesirUniversty
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, nutrition, inflammation

Outcome Measures

Primary Outcomes (4)

• A questionnaire form

  A questionnaire form to evaluate the demographic information

  Through study completion, an average of 4 month

• Nutritional status and habits;

  * Nutrient consumption frequencies * 24-hour retrospective food consumption record

  Through study completion, an average of 4 month

• Functional status of the patients.

  HAQ (Health Assessment Questionnaire)

  Through study completion, an average of 4 month

• Disease activity of the patients

  Simple Disease Activity Index (SDAI)

  Through study completion, an average of 4 month

Interventions

questionnaire form OTHER

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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,

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Balikesir University: lead

Study Sites (1)

Balikesir University

Balıkesir, 10145, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Inflammation

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bilal UYSAL, MD

  Balikesir University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: February 8, 2022
• Study Start: December 20, 2021
• Primary Completion: April 29, 2022
• Study Completion: May 31, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

TU (1)