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Scleroderma Patients' nutrition under the microscope

NCT ID NCT04301596

Knowledge-focused Sponsor: University Hospital, Montpellier Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 150 adults with systemic sclerosis (scleroderma) for two years to track their nutritional health. Researchers measured weight, diet, and disease severity every six months. If malnutrition was found, patients received dietary advice or supplements. The goal was to learn how common malnutrition is and whether simple nutritional help can make a difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to better ways to detect and treat malnutrition in scleroderma patients, improving their overall health.
What could go wrong
This is an observational study, not a treatment trial. It may not lead to any new therapies, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

150 people

The number who actually took part.

Started

Jun 2020

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic sclerosis

Contacts and locations

Locations

  • Montpellier University Hospital

    Montpellier, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.