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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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04301596
Study type Observational
Source University Hospital, Montpellier
Contact Alexandre MARIA, MD, PhD
Phone +33467337332
Email a-maria@chu-montpellier.fr
Status Recruiting
Phase
Start date June 12, 2020
Completion date October 12, 2024

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