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

NCT ID: NCT07277491

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

460 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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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

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Spondyloarthritis (SpA) Psoriatic Arthritis (PsA) Systemic Lupus Erythematous (SLE) Systemic Sclerosis (SSc) Rheumatoid Arthritis (RA

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

No interventions assigned to this group

control cases matched for age and sex

control cases selected from healthy volunteers matched for age and sex

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Reem Mahmoud Lotfy

Rheumatology Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dina Ossama Abdulazim, assistant professor

Role: PRINCIPAL_INVESTIGATOR

Rheumatology and Rehabilitation Department, Faculty of Medicine, Cairo University

Locations

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

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Reem Mahmoud Lotfy, Rheumatology Specialist

Role: CONTACT

+201091940005 ext. +201061754058

Tamer Atef Gheita, Professor of rheumatology

Role: CONTACT

+201004567975

Facility Contacts

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dina ossama Abdulazim, assistant professor

Role: primary

+201001800054

References

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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.

Reference Type BACKGROUND
PMID: 35145987 (View on PubMed)

Olsen 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.

Reference Type BACKGROUND
PMID: 33233336 (View on PubMed)

Malone 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.

Reference Type BACKGROUND
PMID: 34936131 (View on PubMed)

Klak 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.

Reference Type BACKGROUND
PMID: 27407222 (View on PubMed)

Vellas 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.

Reference Type BACKGROUND
PMID: 9990575 (View on PubMed)

Detsky 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.

Reference Type BACKGROUND
PMID: 3820522 (View on PubMed)

Alwall 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.

Reference Type BACKGROUND
PMID: 3521553 (View on PubMed)

Correa-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.

Reference Type BACKGROUND
PMID: 30884776 (View on PubMed)

Aparicio-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.

Reference Type BACKGROUND
PMID: 28294088 (View on PubMed)

Allanore 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.

Reference Type BACKGROUND
PMID: 27189141 (View on PubMed)

Other Identifiers

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MD-66-2023

Identifier Type: -

Identifier Source: org_study_id

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