Assessment of Nutritional Status in Systemic Sclerosis (NUTRISCLER)

University Hospital Center (CHU)

Status: Enrolling

Conditions: Systemic Sclerosis

Treatments: Other: Collection of data

Study type: Observational

Funder types: Other

Identifiers

NCT04301596

RECHMPL19_0409

UF7840 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

150 participants in 1 patient group

SSc patients

Treatment:

Other: Collection of data