Spondyloarthritis (SpA)NCT07277491
Assessment of Nutritional Status in Rheumatic Diseases and Association to Disease Activity
An observational study of Spondyloarthritis (SpA) and Psoriatic Arthritis (PsA), run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spondyloarthritis (SpA), Psoriatic Arthritis (PsA), Systemic Lupus Erythematous (SLE)
- How many people
- 460 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Mar 2026
- How long will I take part?
- 5 Days
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients diagnosed with rheumatic diseases including RA, SpA, SLE and SSc.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department: Rheumatology and Rehabilitation Department, Faculty of Medicine, Cairo University
Cairo, 12613
About this study
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.
Read the 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 .
- Conditions
- Spondyloarthritis (SpA), Psoriatic Arthritis (PsA), Systemic Lupus Erythematous (SLE), Systemic Sclerosis (SSc), Rheumatoid Arthritis (RA
- Keywords
- nutritional status, rheumatic diseases, disease activity
- Medical subject headings
- Spondylarthritis, Arthritis, Psoriatic, Scleroderma, Systemic, Arthritis, Rheumatoid, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Nutritional Status as Assessed by the Prognostic Nutritional Index (PNI)
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
Measured: Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.
Nutritional Risk as Assessed by the Nutritional Risk Index (NRI)
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
Measured: Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.
Nutritional Status as Assessed by the Subjective Global Assessment (SGA)
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.
Measured: 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)
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).
Measured: Assessed during routine clinic visits between January 1, 2023, and December 30, 2025
Secondary outcomes (5)
corrolation between Body Mass Index (BMI) and disease activity
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.
Measured: Assessed during routine clinic visits between January 1, 2023, and December 30, 2025
corrolation between Prognostic Nutritional Index (PNI) and disease activity
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.
Measured: Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.
corrolation between Nutritional Risk Index (NRI) and disease activity
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
Measured: 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
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.
Measured: Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.
Duration of Rheumatic Disease
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
Measured: Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Jan 2023
- Primary completion28 Feb 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Spondyloarthritis (SpA)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 460 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Mahmoud Lotfy, Cairo University
- Investigators
- Dina Ossama Abdulazim, assistant professor, Principal investigator, Rheumatology and Rehabilitation Department, Faculty of Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277491
- Sponsor's protocol ID
- MD-66-2023
- Status last verified
- Jun 2026
- First submitted
- 5 Sep 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu H, Jiao J, Zhu M, Wen X, Jin J, Wang H, Lv D, Zhao S, Sun X, Wu X, Xu T. Nutritional Status According to the Short-Form Mini Nutritional Assessment (MNA-SF) and Clinical Characteristics as Predictors of Length of Stay, Mortality, and Readmissions Among Older Inpatients in China: A National Study. Front Nutr. 2022 Jan 25;9:815578. doi: 10.3389/fnut.2022.815578. eCollection 2022.
PubMed 35145987Olsen MN, Tangvik RJ, Halse AK. Evaluation of Nutritional Status and Methods to Identify Nutritional Risk in Rheumatoid Arthritis and Spondyloarthritis. Nutrients. 2020 Nov 21;12(11):3571. doi: 10.3390/nu12113571.
PubMed 33233336Malone A, Mogensen KM. Key approaches to diagnosing malnutrition in adults. Nutr Clin Pract. 2022 Feb;37(1):23-34. doi: 10.1002/ncp.10810. Epub 2021 Dec 22.
PubMed 34936131Klak A, Borowicz J, Manczak M, Grygielska J, Samel-Kowalik P, Raciborski F. Current nutritional status of patients with rheumatic diseases in the population of Poland. Reumatologia. 2015;53(1):26-33. doi: 10.5114/reum.2015.50554. Epub 2015 Apr 10.
PubMed 27407222Vellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, Albarede JL. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition. 1999 Feb;15(2):116-22. doi: 10.1016/s0899-9007(98)00171-3.
PubMed 9990575Detsky AS, McLaughlin JR, Baker JP, Johnston N, Whittaker S, Mendelson RA, Jeejeebhoy KN. What is subjective global assessment of nutritional status? JPEN J Parenter Enteral Nutr. 1987 Jan-Feb;11(1):8-13. doi: 10.1177/014860718701100108.
PubMed 3820522Alwall N. Historical perspective on the development of the artificial kidney. Artif Organs. 1986 Apr;10(2):86-99. doi: 10.1111/j.1525-1594.1986.tb02526.x. No abstract available.
PubMed 3521553Correa-Rodriguez M, Pocovi-Gerardino G, Callejas-Rubio JL, Fernandez RR, Martin-Amada M, Cruz-Caparros MG, Ortego-Centeno N, Rueda-Medina B. The Prognostic Nutritional Index and Nutritional Risk Index Are Associated with Disease Activity in Patients with Systemic Lupus Erythematosus. Nutrients. 2019 Mar 16;11(3):638. doi: 10.3390/nu11030638.
PubMed 30884776Aparicio-Soto M, Sanchez-Hidalgo M, Alarcon-de-la-Lastra C. An update on diet and nutritional factors in systemic lupus erythematosus management. Nutr Res Rev. 2017 Jun;30(1):118-137. doi: 10.1017/S0954422417000026. Epub 2017 Mar 15.
PubMed 28294088Allanore Y, Simms R, Distler O, Trojanowska M, Pope J, Denton CP, Varga J. Systemic sclerosis. Nat Rev Dis Primers. 2015 Apr 23;1:15002. doi: 10.1038/nrdp.2015.2.
PubMed 27189141