Efficacy of Fish Oil in Multiple Sclerosis (EFOMS)

Coordinación de Investigación en Salud, Mexico

Status and phase: Completed; Phase 4

Conditions: Relapsing- Remitting Multiple Sclerosis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Fish Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT01842191

FOMS

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Fish oil

Experimental group

Treatment:

Dietary Supplement: Fish Oil

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo