Assessment of Nutritional Status in Rheumatic Diseases and Association to Disease Activity

March 6, 2026 updated by: Reem Mahmoud Lotfy, Cairo University
The aim of the present work is to assess the nutritional status among different rheumatic diseases patients and to study its association with the corresponding diseases activity.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Rheumatoid arthritis (RA) is an autoimmune, progressive, systemic disease of connective tissue. It is characterized by arthritis (symmetrical in most cases), extra-articular and systemic change. Spondyloarthritis (SpA) is an interconnected group of rheumatic disorders including ankylosing spondylitis (AS) and psoriatic arthritis (PsA), characterized by common clinical symptoms and a similar genetic background .Systemic Lupus Erythematous (SLE) is a chronic connective tissue disease characterized by a multi-system inflammatory disorder with immune system imbalance .Systemic sclerosis (SSc) is an immune-mediated rheumatic disease characterized by fibrosis of the skin and internal organs as well as vasculopathy .

Nutritional status has been widely related to immunity; under-nutrition is associated with immunosuppression and increased susceptibility to infection whereas over-nutrition is associated with low-grade chronic inflammation increasing the risk and affecting the prognosis in metabolic, cardiovascular, and autoimmune diseases .

Patients with rheumatic diseases are prone to develop malnutrition as their medications often affect appetite, nutrient absorption and digestion.Despite the high incidence of malnutrition and its consequences, there is no universally accepted definition for diagnosing nutritional deficiencies, and nutritional assessment still relies on analyses of a combination of several anthropometric, biochemical, immunological, functional and body composition data, in addition to dietary intake and the evaluation of clinical status.

Four malnutrition diagnostic tools are currently used in adults: Subjective Global Assessment (SGA) ; Mini Nutritional Assessment (MNA) ; Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition malnutrition consensus characteristics; and Global Leadership Initiative on Malnutrition criteria.

Certain objective nutritional assessment indices reflect the immune nutritional status of patients, such as the prognostic nutritional index (PNI) ; and the nutritional risk index (NRI) which are calculated using serum albumin level and lymphocyte count, were found to be related to the nutritional status and disease activity in SLE patients .

Study Type

Observational

Enrollment (Estimated)

460

Contacts and Locations

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

Study Contact

  • Name: Reem Mahmoud Lotfy, Rheumatology Specialist
  • Phone Number: +201061754058 +201091940005
  • Email: reemaaz2000@yahoo.com

Study Contact Backup

  • Name: Tamer Atef Gheita, Professor of rheumatology
  • Phone Number: +201004567975
  • Email: gheitamer@cu.edu.eg

Study Locations

  • Egypt
      • Cairo, Egypt, 12613
        • Recruiting
        • Department: Rheumatology and Rehabilitation Department, Faculty of Medicine, Cairo University
        • Contact:
        • Principal Investigator:
          • Tamer Atef Gheita, Professor

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Population of study: Patients of both genders were recruited in this study. Study subjects were patients with different rheumatic diseases attending the outpatient Rheumatology Clinic. Patients who visited the clinic from January 2023 to December 2025 were asked to participate after being provided with an explanation of the work.

Study location: Study was conducted in the outpatient clinics of the Rheumatology Department, Cairo University Hospitals as well as in the Health Insurance Hospital, Aswan Governorate.

Description

Inclusion Criteria:

Patients diagnosed with rheumatic diseases including RA, SpA, SLE and SSc.

Exclusion Criteria:

  1. Patients who are unable to comply with the physician assessment.
  2. Patients with other connective tissue diseases, neurological diseases, malignancy, heart failure or severe renal dysfunction was excluded, as these diseases affect the muscle mass causing sarcopenia.
  3. Advanced liver diseases

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

Cohorts and Interventions

Group / Cohort
cases with different rheumatic diseases
135 patients with different rheumatic diseases who attended the outpatient Rheumatology Clinic, Cairo University Hospitals as well as the Health Insurance Hospital, Aswan Governorate Patients diagnosed with rheumatic diseases including RA,SpA,SLE and SSc were included
control cases matched for age and sex
control cases selected from healthy volunteers matched for age and sex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional Status as Assessed by the Prognostic Nutritional Index (PNI)
Time Frame: Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.

The Prognostic Nutritional Index (PNI) is an index score calculated using the formula: Serum Albumin (g/L) + 5 × Total Lymphocyte Count (/mm³).

Unit of Measure: Calculated Index Score Interpretation: Higher scores indicate better nutritional status
Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.
Nutritional Risk as Assessed by the Nutritional Risk Index (NRI)
Time Frame: Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.

The Nutritional Risk Index (NRI) is an index score calculated based on serum albumin levels and the percentage of weight loss.

Unit of Measure: Calculated Index Score Interpretation: Higher scores indicate a lower nutritional risk
Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.
Nutritional Status as Assessed by the Subjective Global Assessment (SGA)
Time Frame: Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.

The Subjective Global Assessment (SGA) is a clinical tool that results in a score based on a patient questionnaire and physical examination.

Unit of Measure: Score on a 7-point scale Interpretation: Higher scores indicate better nutritional status.
Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.
Nutritional Status as Assessed by the Mini Nutritional Assessment - Short Form (MNA-SF)
Time Frame: Assessed during routine clinic visits between January 1, 2023, and December 30, 2025

The Mini Nutritional Assessment - Short Form (MNA-SF) is a screening tool consisting of a questionnaire administered to the patient.

Unit of Measure: Score on a 14-point scale Interpretation: Scores are categorized as: 12-14 (normal nutritional status), 8-11 (at risk of malnutrition), or 0-7 (malnourished).
Assessed during routine clinic visits between January 1, 2023, and December 30, 2025

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
corrolation between Body Mass Index (BMI) and disease activity
Time Frame: Assessed during routine clinic visits between January 1, 2023, and December 30, 2025

Body Mass Index (BMI) will be calculated as weight in kilograms divided by the square of height in meters (kg/m^2). This will be reported as a continuous variable. Additionally, the percentage of participants in each standard BMI category (e.g., underweight, normal, overweight, obese) will be determined.

  • Unit of Measure: kg/m^2 and Percentage of participants.
Assessed during routine clinic visits between January 1, 2023, and December 30, 2025
corrolation between Prognostic Nutritional Index (PNI) and disease activity
Time Frame: Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.

PrognostiThe Prognostic Nutritional Index (PNI) score will be calculated using the formula: Serum Albumin (g/L) + 5 × Total Lymphocyte Count (/mm³). The resulting score, where higher values indicate better nutritional status, will be reported as a continuous variable.

  • Unit of Measure: Calculated Index Score.
Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.
corrolation between Nutritional Risk Index (NRI) and disease activity
Time Frame: Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.

The Nutritional Risk Index (NRI) score will be calculated based on serum albumin levels and patient weight changes. The resulting score, where higher values indicate lower nutritional risk, will be reported as a continuous variable.

  • Unit of Measure: Calculated Index Score
Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.
Corrolation between Nutritional Status Categorization by Subjective Global Assessment (SGA) and disease activity
Time Frame: Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.

The Subjective Global Assessment (SGA) will be used to classify participants into distinct nutritional categories: well-nourished, mildly/moderately malnourished, or severely malnourished.

  • Unit of Measure: Percentage of participants in each category.
Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.
Duration of Rheumatic Disease
Time Frame: Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.

The duration of a patient's rheumatic disease is recorded from the date of initial diagnosis as documented in their medical history. This variable will be used to assess the correlation between disease duration and various measures of nutritional status.

Unit of Measure: Years
Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Dina Ossama Abdulazim, assistant professor, Rheumatology and Rehabilitation Department, Faculty of Medicine, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2023

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

September 5, 2025

First Submitted That Met QC Criteria

November 29, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-66-2023

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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