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NCT Number: NCT05227885

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Balikesir University

Balıkesir, 10145, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. A questionnaire form

    Time frame: Through study completion, an average of 4 month

    A questionnaire form to evaluate the demographic information

  2. Nutritional status and habits;

    Time frame: Through study completion, an average of 4 month

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

  3. Functional status of the patients.

    Time frame: Through study completion, an average of 4 month

    HAQ (Health Assessment Questionnaire)

  4. Disease activity of the patients

    Time frame: Through study completion, an average of 4 month

    Simple Disease Activity Index (SDAI)

Sponsors and collaborators

Lead sponsor

Balikesir University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 8, 2022
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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