The Prevalence of Malnutrition and Its Association With Disability in Patients With Relapsing-Remitting Multiple Sclerosis: A Prospective Cross-Sectional Observational Study
Study on Malnutrition and Disability in Multiple Sclerosis Patients
Plain English Summary
The Prevalance of Malnutrition and Its Association With Disability in Patients With Relapsing-Remitting Multiple Sclerosis is a Not Applicable clinical trial sponsored by Antalya Training and Research Hospital studying Relapsing Remitting Multiple Sclerosis (RRMS), Malnutrition or Risk of Malnutrition. This study looks at how common malnutrition is in people with relapsing-remitting multiple sclerosis (RRMS) and if it's linked to disability. It's for adults diagnosed with RRMS and healthy adults who will serve as a comparison group. Participants will have their nutritional status, body composition, and other health factors assessed. There are no alternative treatments being tested; this is an observational study. The trial aims to enroll 169 participants.
Official Summary
This prospective observational study aims to determine the prevalence of malnutrition in patients with relapsing-remitting multiple sclerosis and to evaluate its association with disability. Nutritional status will be assessed using the Mini Nutritional Assessment-Short Form, and body composition will be evaluated with bioelectrical impedance analysis and anthropometric measurements. The study will also assess urinary incontinence, depression, and anger-related features, and compare the findings with those of healthy controls.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 18 or older and have been diagnosed with RRMS. You cannot join if you have another serious medical condition that affects walking, or if you've had an MS relapse or steroid treatment recently. Healthy volunteers aged 18+ are also needed for comparison. You must be willing to provide informed consent to participate. This trial is studying Relapsing Remitting Multiple Sclerosis (RRMS), Malnutrition or Risk of Malnutrition, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how many RRMS patients are found to be malnourished, which helps understand the scale of the problem. The specific primary outcome measures are: Prevalence of malnutrition assessed by Mini Nutritional Assessment-Short Form (At baseline). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it aims to understand if poor nutrition contributes to disability in MS patients, potentially leading to better care strategies. This research targets Relapsing Remitting Multiple Sclerosis (RRMS), Malnutrition or Risk of Malnutrition, where improved treatment options are needed.
Investor Insight
This observational study provides insights into a potential unmet need in MS patient care, highlighting the importance of nutritional assessment in managing the disease.
Is This Trial Right for Me?
Ask your doctor about the study and how malnutrition might affect your MS. Participation involves assessments of your nutritional status, body measurements, and other health factors. You will need to provide informed consent before joining. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 169 participants
Primary Outcomes
- Prevalence of malnutrition assessed by Mini Nutritional Assessment-Short Form (At baseline)
Secondary Outcomes
- Expanded Disability Status Scale score (At baseline)
- Height as an anthropometric measurement (At baseline)
- Body weight as an anthropometric measurement (At baseline)
- Body mass index as an anthropometric measurement (At baseline)
- Waist circumference as an anthropometric measurement (At baseline)
Full Eligibility Criteria
Inclusion Criteria: * Age 18 years or older * Diagnosis of relapsing-remitting multiple sclerosis for the patient group * Absence of another medical condition that markedly impairs walking, such as severe cardiovascular disease, respiratory disease, or major orthopedic conditions * Healthy volunteers willing to participate as controls * Written informed consent provided Exclusion Criteria: * EDSS score ≥7 in the relapsing-remitting multiple sclerosis group * Multiple sclerosis relapse during the last 30 days * Systemic glucocorticoid treatment during the last 30 days * History of musculoskeletal disease * History of neuromuscular junction disease
Trial Locations
- Antalya Training and Research Hospital, Antalya, Antalya, Turkey (Türkiye)
Frequently Asked Questions
What is clinical trial NCT07497126?
NCT07497126 is a Not Applicable OBSERVATIONAL study titled "The Prevalance of Malnutrition and Its Association With Disability in Patients With Relapsing-Remitting Multiple Sclerosis." It is currently active, not recruiting and is sponsored by Antalya Training and Research Hospital. The trial targets enrollment of 169 participants.
What conditions does NCT07497126 study?
This trial investigates treatments for Relapsing Remitting Multiple Sclerosis (RRMS), Malnutrition or Risk of Malnutrition. The primary condition under study is Relapsing Remitting Multiple Sclerosis (RRMS).
What does Not Applicable mean for NCT07497126?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07497126?
This trial is currently "Active, Not Recruiting." It started on 2024-11-04. The estimated completion date is 2026-04-15.
Who is sponsoring NCT07497126?
NCT07497126 is sponsored by Antalya Training and Research Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07497126?
The trial aims to enroll 169 participants. The trial status is active, not recruiting.
How is NCT07497126 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07497126?
The primary outcome measures are: Prevalence of malnutrition assessed by Mini Nutritional Assessment-Short Form (At baseline). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07497126 being conducted?
This trial is being conducted at 1 site, including Antalya, Antalya (Turkey (Türkiye)).
Where can I find official information about NCT07497126?
The official record for NCT07497126 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07497126. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07497126 testing in simple terms?
This study looks at how common malnutrition is in people with relapsing-remitting multiple sclerosis (RRMS) and if it's linked to disability. It's for adults diagnosed with RRMS and healthy adults who will serve as a comparison group.
Why is this trial significant?
This trial is important because it aims to understand if poor nutrition contributes to disability in MS patients, potentially leading to better care strategies.
What are the potential risks of participating in NCT07497126?
Potential risks are minimal as this is an observational study, but may include discomfort during measurements. Side effects are not expected from the study procedures themselves, but relate to the conditions being studied. The study will assess factors like urinary incontinence and depression, which are known challenges for MS patients. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07497126?
Ask your doctor about the study and how malnutrition might affect your MS. Participation involves assessments of your nutritional status, body measurements, and other health factors. You will need to provide informed consent before joining. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07497126 signal from an investment perspective?
This observational study provides insights into a potential unmet need in MS patient care, highlighting the importance of nutritional assessment in managing the disease. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will have their nutritional status, body composition, and other health factors assessed. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Relapsing Remitting Multiple Sclerosis (RRMS) Trials
View all Relapsing Remitting Multiple Sclerosis (RRMS) clinical trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.