A medical nutrition formula for the treatment of relapsing multiple sc
A novel medical nutrition formula indicates a possible new approach for relapsing multiple sclerosis treatment: a double-blind, randomized, placebo-controlled clinical trial of efficacy and safety
What it found
A paper reports the results; we have not read it yet. See Papers below.
What it measured
Main measures
Current primary outcome measure(s) as of 11/04/2012: The study was designed to end 30 months after enrolment and neurological and clinical assessments were scheduled at entry baseline and 3, 9, 15, 21 and 24 months on-treatment. Patients were also seen at unscheduled visits within 48 hours after the onset of new neurologic symptoms. Primary outcomes were the number of relapses per patient, mean nu
Relapses
Other measures (1)
Current secondary outcome measure(s) as of 11/04/2012: 1. The key secondary end point was the time to confirmed disability progression, defined as an increase of one point in the EDSS score, confirmed after 6 months, with an absence of relapse at the time of assessment and with all EDSS scores measured during that time meeting the criteria for disability progression. 2. A post-hoc analysis was per
Disability progressionRelapsesMRI lesions
Who could take part
Relapsing MS · 18 and over
Show the full criteria
Inclusion criteria
Inclusion: 1. Men and women 2. Ages of between 18 and 65 years 3. Diagnosis of relapsing remitting Multiple Sclerosis (RRMS) 4. A score of 0.0 to 5.5 on the Expanded Disability Status Scale (EDSS) 5. Undergone MRI showing lesions consistent with MS 6. At least one medically documented relapse within the 24 months before beginning of the study and who had been receiving approximately the same disease modified treatment (DMT) during the two years before enrolment Exclusion: 1. Prior immunosuppressants or monoclonal antibodies therapy 2. Pregnancy or nursing 3. Any severe disease other than MS compromising organ function 4. Patients with primary progressive or secondary progressive disease 5. Patients known to have a history of recent drug or alcohol abuse 6. Unable to follow the protocol from the intent to treat analysis (ITT) 7. Any patients that changed type of the disease (i.e RRMS to secondary progressive) 8. Consumption of any additional food supplement formula, vitamin of any type or any form of polyunsaturated fatty acid (PUFA) at any time during the trial
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Background and study aims Multiple sclerosis is a chronic disease that attacks the brain, spinal cord and optic nerves. In milder cases there may be numbness in the limbs, while in severe cases the patient becomes paralyzed and/or blind. This study addresses the major issue of the relationship between nutrition and neurodegenerative diseases, specifically multiple sclerosis. Omega-3 and omega-6 fatty acids have been found to be involved in the recovery mechanisms and restoration and regeneration of the nerves. None of the existing drugs for multiple sclerosis reliably produces a complete remission of symptoms, none have been shown to be able to trigger recovery mechanisms, and all are associated with severe side effects. Hence, there remains a major need for new and more effective treatments. The aim of this study is to test the effectiveness and safety of a new formula for multiple sclerosis treatment. Who can participate? Patients aged 18 to 65 with relapsing remitting multiple sclerosis What does the study involve? Participants are randomly allocated to one of four groups. Group A receive a daily oral liquid formula containing fatty acids and vitamins. Group C receive an antioxidant vitamin. Group B receive a mixture of treatments A and C. Group D receive a placebo (dummy) formula of pure virgin olive oil. All participants take their allocated supplement once daily for a total of 30 months. Participants are assessed at the start of the study, after 3, 9, 15, 21 and 24 months of treatment, and after the onset of any new symptoms, and are followed up for an additional 12 months after the end of the study. What are the possible benefits and risks of participating? Participants are asked to visit the hospital more frequently and therefore are monitored more closely. Participating will help the trialists to investigate a new possible approach for the treatment of neurodegenerative diseases and specifically multiple sclerosis. The risks are extremely low and are limited to nausea. The substances used in the formulas can normally be found in an everyday diet. Where is the study run from? Cyprus Institute of Neurology and Genetics When is the study starting and how long is it expected to run for? July 2007 to December 2010 Who is funding the study? Cyprus Ministry of Commerce, Industry and Tourism Who is the main contact? Dr Ioannis Patrikios loukaide@cing.ac.cy
Papers
Results
results
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History
Started
Jul 2007
Finished
Dec 2009