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NCT04301596Completed

Assessment of Nutritional Status in Systemic Sclerosis

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

Source: ClinicalTrials.gov · Last updated 12 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
150 (actual)
First submitted
5 Mar 2020
Start date
12 Jun 2020
Primary completion date
11 Feb 2025
Lead sponsor
University Hospital, Montpellier
NCT number
NCT04301596

What you commit to

  • Study type: Observational
  • Participants enrolled: 150
  • From 12 Jun 2020 to the primary completion date, 11 Feb 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Montpellier University Hospital
Coordinator of this site? Confirm its status
MontpellierFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.