Efficacy of Fish Oil in Multiple Sclerosis

Study Overview
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Brief Summary
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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
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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).

Official Title
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Efficacy of Fish Oil on Serum TNFα, IL-1β, IL-6, Oxidative Stress Markers in Multiple Sclerosis Treated With Interferon Beta 1-b

Conditions
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Relapsing- Remitting Multiple Sclerosis

Intervention / Treatment
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* Dietary Supplement: Fish Oil
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish oil<br> | Dietary Supplement: Fish Oil<br>* 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.<br>* Other names: Omega 3;|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Orally, 4 Capsules per day, (glycerin, water purified, tocopherol, sunflower oil and titanium dioxide), during 12 months.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNF alpha | Serum TNF alpha levels, at baseline, 3, 6, 9 and 12 months. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-1 beta, IL-6, Lipoperoxides, nitric oxide | Serum IL-1 beta, IL-6, Lipoperoxides, nitric oxide levels at baseline, 3, 6, 9 and 12 months. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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R-R MS