A medical nutrition formula for the treatment of relapsing multiple sclerosis

Not Applicable

Completed

• Conditions: Multiple sclerosis; Nervous System Diseases

• Registration Number: ISRCTN87818535
• Lead Sponsor: Ministry of Commerce Industry and Tourism (Cyprus)

Brief Summary

2013 results in https://pubmed.ncbi.nlm.nih.gov/23599375/ (added 18/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-12-31
• Study Start: 2011-05-19
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified