Efficacy of Fish Oil on Serum TNFα, IL-1β, IL-6, Oxidative Stress Markers in Multiple Sclerosis Treated With Interferon Beta 1-b
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- TNF alpha
Study Overview
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.
Detailed Description
Current research findings suggest that Omega-3 polyunsaturated fatty acids (PUFA) such as eicosahexanoic acid (EPA) and docosahexaenoic acid (DHA) contained in fish oil may have anti-inflammatory, antioxidant and neuroprotective effects. 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. 50 patients with relapsing-remitting MS were enrolled. The experimental group received orally 4 g/day of fish oil for 12 months. The primary outcome was serum TNFα levels; Secondary outcomes were IL-1β, IL-6, nitric oxide catabolites, lipoperoxides, progression on the expanded disability status scale (EDSS) and annualized relapses rate (ARR).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
TNF alpha
Time Frame: 3 months
Serum TNF alpha levels, at baseline, 3, 6, 9 and 12 months.
Secondary Outcomes
- IL-1 beta, IL-6, Lipoperoxides, nitric oxide(3 months)
Investigators
Genaro Gabriel Ortiz
Investigador titular D
Coordinación de Investigación en Salud, Mexico