Assessment of Nutritional Status in Systemic Sclerosis

NCT04301596 | Completed

• 2 other identifiers: RECHMPL19_0409UF7840
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The main theme of the cohort of systemic sclerosis (SSc) patients is the determination of nutritional status, its evolution and the evaluation of its management in patients with scleroderma. The main objectives are :

• To determine the incidence of malnutrition and its main determinants (disease characteristics, severity, eating habits, physical activity) in patients with scleroderma.
• For patients with undernutrition at inclusion or at 18 months follow-up: evaluate the impact of a standardized nutritional intervention (dietary advice, oral supplements, artificial, enteral or parenteral nutrition) on nutritional and disease parameters. Follow-up visits will take place every 6 months for 2 years. (M6, M12, M18 et M24). During each visit: a clinical examination, with anthropometric measurements, a 3-day dietary survey and a blood sample (10 ml), completion a multiple-choice of quality of life and physical activity evaluation. Paraclinical evaluation : echocardiography, lung function tests, screening for osteoporosis (M6 and M18). If undernutrition is detected during a follow-up visit, the subject will be referred to a specialized service.

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (3)

• Incidence of malnutrition

  Incidence of malnutrition will be measured as a loss of more than 10% of body weight or a body mass index (BMI) less than 21 kg/m2

  6 months

• Idetification of risk factors associated with malnutrition

  Collection of data related to SSc disease burden

  6 months

• Success of the nutritional intervention

  body weight gain \> 5%

  6 months

Study Arms (1)

SSc patients

Other: Collection of data

Interventions

Collection of data OTHER

different set of data will be collected over a 6 months period

SSc patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is patients aged 18 or more with scleroderma. From preliminary data obtained in our department, we can estimate that 50% of participants will meet the definition of malnutrition (BMI\<21kg/m2 or weigh loss \>10% in months) at baseline.

You may qualify if:

• All SSc patients aged 18 or more
• Patient followed at the Montpellier University Hospital
• Patients must fulfil the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2013 criteria for SSc.
• Health insurance (affiliation to social security)
• Collection of non-opposition to participate in the study

You may not qualify if:

• Patient under the protection of justice curatorship / guardianship;
• Patients who have already planned to move out of the region in the next two years, making the follow-up impossible.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Montpellier University Hospital

Montpellier, France

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Alexandre MARIA

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 10, 2020
• Study Start: June 12, 2020
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)