Assessment of Nutritional Status in Systemic Sclerosis

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.

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Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montpellier University Hospital

Montpellier, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Collection of data

Other

different set of data will be collected over a 6 months period

Primary outcomes

Incidence of malnutrition

Time frame: 6 months

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
Idetification of risk factors associated with malnutrition

Time frame: 6 months

Collection of data related to SSc disease burden
Success of the nutritional intervention

Time frame: 6 months

body weight gain > 5%

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: NUTRISCLER

Important dates

Study start: 2020
Primary completion: 2025
Study completion: 2025
First posted: Mar 10, 2020
Registry last updated: Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed