Clinical Trials Directory

Trials / Completed

CompletedNCT01842191

Efficacy of Fish Oil in Multiple Sclerosis

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Coordinación de Investigación en Salud, Mexico · Other Government
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Not accepted

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

Interventions

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

Timeline

Start date
2010-05-01
Primary completion
2011-12-01
Completion
2012-12-01
First posted
2013-04-29
Last updated
2013-05-22

Locations

1 site across 1 country: Mexico

Source: ClinicalTrials.gov record NCT01842191. Inclusion in this directory is not an endorsement.

Efficacy of Fish Oil in Multiple Sclerosis (NCT01842191) · Clinical Trials Directory