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
- Diseases
- Systemic sclerosis (scleroderma)
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Montpellier University Hospital Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.