Efficacy of Fish Oil in Multiple Sclerosis
EFOMS
Efficacy of Fish Oil on Serum TNFα, IL-1β, IL-6, Oxidative Stress Markers in Multiple Sclerosis Treated With Interferon Beta 1-b
1 other identifier
interventional
50
1 country
1
Brief Summary
The aim of the present work was to evaluate the efficacy of fish oil supplementation on serum proinflammatory cytokines levels, oxidative stress markers and disease progression in MS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2010
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 25, 2013
CompletedFirst Posted
Study publicly available on registry
April 29, 2013
CompletedMay 22, 2013
May 1, 2013
1.6 years
April 25, 2013
May 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
TNF alpha
Serum TNF alpha levels, at baseline, 3, 6, 9 and 12 months.
3 months
Secondary Outcomes (1)
IL-1 beta, IL-6, Lipoperoxides, nitric oxide
3 months
Other Outcomes (1)
Expanded Disability Status Scale (EDSS) and Annualized rate of relapses (ARR)
6 months
Study Arms (2)
Fish oil
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Patients received 4g/day Omega Rx capsules (Dr. Sears zone diet) containing 0.8 g EPA and 1.6 g DHA and excipient (glycerin, water purified, tocopherol, sunflower oil and titanium dioxide), during 12 months.
Orally, 4 Capsules per day, (glycerin, water purified, tocopherol, sunflower oil and titanium dioxide), during 12 months.
Eligibility Criteria
You may qualify if:
- Patients had clinically definite and magnetic resonance image supported MS
- Had at least one relapse in the year before entry into the study
- EDSS score of 0-5
- Treated with subcutaneous 250 μg interferon beta-1b (Betaseron, Bayer)
You may not qualify if:
- they were taking another supplement
- had progressive forms of MS
- had history of severe depression
- had history of acute liver or renal dysfunction
- had history of tobacco, drug or alcohol abuse
- had intolerance, contraindication or allergy to fish oil
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IMSS, Specialties Hospital, Neurology Departament
Guadalajara, Jalisco, 44340, Mexico
Related Publications (1)
Ortiz GG, Macias-Islas MA, Pacheco-Moises FP, Cruz-Ramos JA, Sustersik S, Barba EA, Aguayo A. Oxidative stress is increased in serum from Mexican patients with relapsing-remitting multiple sclerosis. Dis Markers. 2009;26(1):35-9. doi: 10.3233/DMA-2009-0602.
PMID: 19242067BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Genaro G Ortiz, phD
Social Security Mexican Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigador titular D
Study Record Dates
First Submitted
April 25, 2013
First Posted
April 29, 2013
Study Start
May 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2012
Last Updated
May 22, 2013
Record last verified: 2013-05