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NCT Number: NCT07277491

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

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.

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Key information

Conditions

Spondyloarthritis (SpA) Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis (PsA) Rheumatic Diseases Rheumatoid Arthritis (RA Scleroderma, Systemic Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Systemic Lupus Erythematous (SLE) Systemic Sclerosis (SSc)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department: Rheumatology and Rehabilitation Department, Faculty of Medicine, Cairo University

Cairo, 12613, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • Patients who are unable to comply with the physician assessment.
  • 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.
  • Advanced liver diseases

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2025
Registry last updated
Jun 30, 2026

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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