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Completed

NCT Number: NCT01842191

Efficacy of Fish Oil in Multiple Sclerosis

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.

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Key information

Conditions

Relapsing- Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

IMSS, Specialties Hospital, Neurology Departament

Guadalajara, Jalisco, 44340, Mexico

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish Oil

Dietary Supplement

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: PUFAS, Omega 3

Placebo

Dietary Supplement

Orally, 4 Capsules per day, (glycerin, water purified, tocopherol, sunflower oil and titanium dioxide), during 12 months.

Other names: Control

Primary outcomes

  1. TNF alpha

    Time frame: 3 months

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

Secondary outcomes

  1. IL-1 beta, IL-6, Lipoperoxides, nitric oxide

    Time frame: 3 months

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

Other outcomes

  1. Expanded Disability Status Scale (EDSS) and Annualized rate of relapses (ARR)

    Time frame: 6 months

    EDSS and ARR at baseline, 6 months and 12 months

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Registry information

Official study title

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

Acronym: EFOMS

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Apr 29, 2013
Registry last updated
May 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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