Efficacy of Fish Oil in Multiple Sclerosis

Phase 4

Completed

• Conditions: Relapsing- Remitting Multiple Sclerosis
• Interventions: Dietary Supplement: Fish Oil; Dietary Supplement: Placebo

• Registration Number: NCT01842191
• Lead Sponsor: Coordinación de Investigación en Salud, Mexico

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 Timeline

• Study Start: 2010-05
• Primary Completion: 2011-12
• Study Completion: 2012-12
• Study First Submitted: 2013-04-25
• Study First Submitted QC: 2013-04-26
• Study First Posted: 2013-04-29
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-20
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fish oil	Fish Oil	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
TNF alpha	3 months	Serum TNF alpha levels, at baseline, 3, 6, 9 and 12 months.

Secondary Outcome Measures

Name	Time	Method
IL-1 beta, IL-6, Lipoperoxides, nitric oxide	3 months	Serum IL-1 beta, IL-6, Lipoperoxides, nitric oxide levels at baseline, 3, 6, 9 and 12 months.

Trial Locations

Locations (1)

IMSS, Specialties Hospital, Neurology Departament; 🇲🇽 Guadalajara, Jalisco, Mexico