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

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.

Study Overview

• Status: Completed
• Conditions: Relapsing- Remitting Multiple Sclerosis
• Intervention / Treatment: Dietary supplement: Fish Oil; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44340
      • IMSS, Specialties Hospital, Neurology Departament

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Orally, 4 Capsules per day, (glycerin, water purified, tocopherol, sunflower oil and titanium dioxide), during 12 months.; Other Names: Control
Experimental: Fish oil	Dietary supplement: Fish Oil; 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.; Other Names: Omega 3; PUFAS

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expanded Disability Status Scale (EDSS) and Annualized rate of relapses (ARR)	EDSS and ARR at baseline, 6 months and 12 months	6 months

Collaborators and Investigators

• Sponsor: Coordinación de Investigación en Salud, Mexico
• Investigators: Principal Investigator: Genaro G Ortiz, phD, Social Security Mexican Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: April 25, 2013
• First Submitted That Met QC Criteria: April 26, 2013
• First Posted (Estimate): April 29, 2013

Study Record Updates

• Last Update Posted (Estimate): May 22, 2013
• Last Update Submitted That Met QC Criteria: May 20, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: R-R MS
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: FOMS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No