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A medical nutrition formula for the treatment of relapsing multiple sclerosis
ISRCTN ISRCTN87818535
DOI 10.1186/ISRCTN87818535
ClinicalTrials.gov identifier
EudraCT number
Public title A medical nutrition formula for the treatment of relapsing multiple sclerosis
Scientific title 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
Acronym N/A
Serial number at source N/A
Study hypothesis 1. Docosahexaenoic acid (DHA)/ Eicosapentaenoic acid (EPA)/ Gamma-Linolenic Acid (GLA)/ linoleic acid (LA) polyunsaturated fatty acids along with specific monounsaturated fatty acids, minor quantity of specific saturated fatty acids and specific antioxidant vitamins (E and A) and gamma-tocopherol within a specific ratio, quantity and quality can possibly interfere with all known pathophysiological mechanisms in multiple sclerosis (MS)
2. This could result in increased treatment efficacy, reduction of annual relapses rate (ARR) and disability accumulation and can possibly trigger remyelination and neuroprotection

As of 05/04/2012, the study design has been amended from single center, double-blinded, randomized, placebo controlled factorial to single center, randomized, double-blind, placebo-controlled, parallel.
Lay summary Lay summary under review 3
Ethics approval Cyprus Bioethics Committee Ref: EEΒΚ/ΕΠ/2005/10 6 September 2005 . www.bioethics.gov.cy
Study design Single center, randomized, double-blind, placebo-controlled, parallel.
Countries of recruitment Cyprus
Disease/condition/study domain Multiple sclerosis
Participants - 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
Participants - 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
Anticipated start date 01/07/2007
Anticipated end date 31/12/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 80 (20% of the total eligible relapsing remitting population in Cyprus). Twenty patients were randomly assigned to each treatment arm.
Interventions 1. The daily oral liquid formula dose of intervention A, was a mixture of:
1.1. EPA (about 1650mg)
1.2. DHA (about 4650mg)
1.3. GLA (about 2000mg)
1.4. LA (about 3850mg)
1.5. Total other omega-3 (about 600mg)
1.6. Total monounsaturated fatty acids (MUFA) (about 1700mg)
1.7. Total saturated fatty acids (SFA) (18:0 about 160mg, 16:0 about 650mg)
1.8. Vitamin A (about 0.6mg)
1.9. Vitamin E (about 22mg)
2. Intervention C was composed of pure γ-tocopherol (760mg) dispersed in pure virgin olive oil (16137 mg) as delivery vehicle
3. Intervention B was the mixture of intervention formula A with Intervention C without the pure virgin olive oil
4. Intervention D (placebo) was composed of pure virgin olive oil (16930mg)
5. Food grade citrus-aroma was added in each intervention formula to make up a total dosage of 19.5ml of solution per day once daily for a total of 30 months
6. The first 6 months of the study were used as normalization period for the interventionsí agents to exert their beneficial effect
7. All preparations and the placebo had identical appearance and smell
8. The bottles containing the syrup were labeled with medication code numbers that were unidentifiable for patients as well as investigators
Primary outcome measure(s) Current primary outcome measure(s) as of 11/04/2012
1. 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
2. Patients were also seen at unscheduled visits within 48 hours after the onset of new neurologic symptoms
3. 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
4. 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
5. 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)
1. 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
2. Patients were also seen at unscheduled visits within 48 hours after the onset of new neurologic symptoms
3. Primary outcomes were the number of relapses per patient, mean number of relapses, frequency of relapses and ARR
4. 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
5. 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)
Secondary outcome measure(s) 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 for 24 weeks (progression could not be confirmed during a relapse)
5. T2-weighted MRI scans of the brain were obtained during enrollment (from patientsí regular medical follow up) and at the end of the two years of the clinical trial duration
Sources of funding Cyprus Ministry of Commerce, Industry and Tourism (Cyprus)
Trial website
Publications
Contact name Dr  Ioannis  Patrikios
  Address 6 International Airport Avenue
Agios Dometios
  City/town Nicosia
  Zip/Postcode 1683
  Country Cyprus
  Tel +357 9909 7856
  Email loukaide@cing.ac.cy
Sponsor Ministry of Commerce Industry and Tourism (Cyprus)
  Address 6 Andreas
Araouzos Street
  City/town Nicosia
  Zip/Postcode 1421
  Country Cyprus
  Tel +357 228 67100
  Fax +357 223 75120
  Email perm.sec@mcit.gov.cy
  Sponsor website: http://<www.mcit.gov.cy>
Date applied 09/05/2011
Last edited 02/08/2012
Date ISRCTN assigned 19/05/2011
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