Efficacy of Fish Oil in Multiple Sclerosis

Relapsing- Remitting Multiple Sclerosis Clinical Trial

— EFOMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01842191
• Other study ID #: FOMS
• Status: Completed
• Phase: Phase 4
• First received: April 25, 2013
• Last updated: May 20, 2013
• Start date: May 2010
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Coordinación de Investigación en Salud
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing- Remitting Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Mexico	IMSS, Specialties Hospital, Neurology Departament	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

Ortiz GG, Macías-Islas MA, Pacheco-Moisés 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Expanded Disability Status Scale (EDSS) and Annualized rate of relapses (ARR)	EDSS and ARR at baseline, 6 months and 12 months	6 months	Yes
Primary	TNF alpha	Serum TNF alpha levels, at baseline, 3, 6, 9 and 12 months.	3 months	Yes
Secondary	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	Yes