Efficacy of Fish Oil in Multiple Sclerosis

NCT ID: NCT01842191

Last Updated: 2013-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2012-12-31

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).

Conditions

Relapsing- Remitting Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Fish oil

Group Type: EXPERIMENTAL

Fish Oil

Intervention Type: 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.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

PUFAS; Omega 3; Control

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coordinación de Investigación en Salud, Mexico

OTHER_GOV

Sponsor Role: lead

Responsible Party

Genaro Gabriel Ortiz

Investigador titular D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Genaro G Ortiz, phD

Role: PRINCIPAL_INVESTIGATOR

Social Security Mexican Institute

Locations

IMSS, Specialties Hospital, Neurology Departament

Guadalajara, Jalisco, Mexico

Countries

Mexico

References

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.

Reference Type: BACKGROUND

PMID: 19242067 (View on PubMed)

Other Identifiers

FOMS

Identifier Type: -

Identifier Source: org_study_id