A medical nutrition formula for the treatment of relapsing multiple sclerosis

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN87818535

Enrollment

Registered

2011-05-19

Start date

2007-07-01

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis Nervous System Diseases Multiple sclerosis

Interventions

The daily oral liquid formula dose of intervention A, was a mixture of: 1. EPA (about 1650mg) 2. DHA (about 4650mg) 3. GLA (about 2000mg)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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 number of relapses, frequency of relapses and ARR. The key primary outcome was the ARR. Relapses were defined as new neurologic symptoms or worsening of pre-existing symptoms (that were stable for at least 1 month) not associated with fever or infection that lasted for at least 24 hours. The patients were followed up for additional 12 months after completion of the trial and the relapses were reported (31/12/2009 to 31/12/2010) Previous primary outcome measure(s): 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 number of relapses, frequency of relapses and ARR. Relapses were defined as new neurologic symptoms or worsening of pre-existing symptoms (that were stable for at least 1 month) not associated with fever or infection that lasted for at least 24 hours. The patients were followed up for additional 12 months after completion of the trial and the relapses were reported (31/12/2009 to 31/12/2010)	—

Measure

Time frame

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 number of relapses, frequency of relapses and ARR. The key primary outcome was the ARR. Relapses were defined as new neurologic symptoms or worsening of pre-existing symptoms (that were stable for at least 1 month) not associated with fever or infection that lasted for at least 24 hours. The patients were followed up for additional 12 months after completion of the trial and the relapses were reported (31/12/2009 to 31/12/2010) Previous primary outcome measure(s): 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 number of relapses, frequency of relapses and ARR. Relapses were defined as new neurologic symptoms or worsening of pre-existing symptoms (that were stable for at least 1 month) not associated with fever or infection that lasted for at least 24 hours. The patients were followed up for additional 12 months after completion of the trial and the relapses were reported (31/12/2009 to 31/12/2010)

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Secondary

Measure	Time frame
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 performed on brain T2-weighted MRI scans at the end of the study for the per-protocol participants of the group receiving the highest effective intervention vs. placebo. The comparison was made only versus the available archival MRI scans up to three months before the enrollment date. MRI scans performed and blinded analyzed at an MRI evaluation center. 3. The final EDSS score was confirmed 6 months after the end of the study 4. We considered disability deteriorating when patient deteriorated by at least 1.0 EDSS point between two successive clinical evaluations in relation to the entry EDSS score that was sustained for 24 weeks (progression could not be confirmed during a relapse) Previous secondary outcome measure(s): 1. 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. The number of patients with new or enlarging T2-weighted lesion load on Brain MRI at two years (end of study) in comparison to the corresponding ones from the enrolment period 3. The final EDSS score was confirmed 6 months after the end of the study 4. We considered disability deteriorating when patient deteriorated by at least 1.0 EDSS point between two successive clinical evaluations in relation to the entry EDSS score that was sustained	—

Measure

Time frame

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 performed on brain T2-weighted MRI scans at the end of the study for the per-protocol participants of the group receiving the highest effective intervention vs. placebo. The comparison was made only versus the available archival MRI scans up to three months before the enrollment date. MRI scans performed and blinded analyzed at an MRI evaluation center. 3. The final EDSS score was confirmed 6 months after the end of the study 4. We considered disability deteriorating when patient deteriorated by at least 1.0 EDSS point between two successive clinical evaluations in relation to the entry EDSS score that was sustained for 24 weeks (progression could not be confirmed during a relapse) Previous secondary outcome measure(s): 1. 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. The number of patients with new or enlarging T2-weighted lesion load on Brain MRI at two years (end of study) in comparison to the corresponding ones from the enrolment period 3. The final EDSS score was confirmed 6 months after the end of the study 4. We considered disability deteriorating when patient deteriorated by at least 1.0 EDSS point between two successive clinical evaluations in relation to the entry EDSS score that was sustained

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Countries

Cyprus

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 23, 2026