Assessment of Nutritional Status in Systemic Sclerosis (NUTRISCLER)

May 2, 2023 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Montpellier, France
        • Recruiting
        • Montpellier University Hospital
        • Contact:
          • Alexandre MARIA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population is patients aged 18 or more with scleroderma. From preliminary data obtained in our department, we can estimate that 50% of participants will meet the definition of malnutrition (BMI<21kg/m2 or weigh loss >10% in months) at baseline.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SSc patients
Other: Collection of data
different set of data will be collected over a 6 months period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
Idetification of risk factors associated with malnutrition
Time Frame: 6 months
Collection of data related to SSc disease burden
6 months
Success of the nutritional intervention
Time Frame: 6 months
body weight gain > 5%
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2020

Primary Completion (Anticipated)

June 12, 2024

Study Completion (Anticipated)

October 12, 2024

Study Registration Dates

First Submitted

March 5, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (Actual)

March 10, 2020

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL19_0409
  • UF7840 (Other Identifier: Montpellier University Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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