Assessment of Nutritional Status in Systemic Sclerosis

Systemic Sclerosis Clinical Trial

— NUTRISCLER  

Official title:

Assessment of Nutritional Status in Systemic Sclerosis: Prospective Cohort Study in Montpellier University Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04301596
• Other study ID #: RECHMPL19_0409
• Secondary ID: UF7840
• Status: Recruiting
• Start date: June 12, 2020
• Est. completion date: October 12, 2024

Study information

• Verified date: May 2023
• Source: University Hospital, Montpellier
• Contact: Alexandre MARIA, MD, PhD
• Phone: +33467337332
• Email: a-maria[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 12, 2024
• Est. primary completion date: June 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Other:
• Collection of data
different set of data will be collected over a 6 months period

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Idetification of risk factors associated with malnutrition	Collection of data related to SSc disease burden	6 months
Primary	Success of the nutritional intervention	body weight gain > 5%	6 months