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Assessment of Nutritional Status in Systemic Sclerosis (NUTRISCLER)

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ClinicalTrials.gov Identifier: NCT04301596
Recruitment Status : Recruiting
First Posted : March 10, 2020
Last Update Posted : May 3, 2023
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Systemic Sclerosis Other: Collection of data

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Nutritional Status in Systemic Sclerosis: Prospective Cohort Study in Montpellier University Hospital
Actual Study Start Date : June 12, 2020
Estimated Primary Completion Date : June 12, 2024
Estimated Study Completion Date : October 12, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Idetification of risk factors associated with malnutrition [ Time Frame: 6 months ]
    Collection of data related to SSc disease burden

  3. Success of the nutritional intervention [ Time Frame: 6 months ]
    body weight gain > 5%


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04301596


Contacts
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Contact: Alexandre MARIA, MD, PhD +33467337332 a-maria@chu-montpellier.fr
Contact: Philippe GUILPAIN p-guilpain@chu-montpellier.fr

Locations
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France
Montpellier University Hospital Recruiting
Montpellier, France
Contact: Alexandre MARIA         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Alexandre MARIA Montpellier University Hospital
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04301596    
Other Study ID Numbers: RECHMPL19_0409
UF7840 ( Other Identifier: Montpellier University Hospital )
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
 Pathologic Processes
Connective Tissue Diseases
Skin Diseases