Trial | NCT01842191  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fish oil ...

  • Study Participants

    50
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.
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 Started
May 31
2010
Primary Completion
Dec 31
2011
Study Completion
Dec 31
2012
Last Update
May 22
2013
Estimate

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: PUFAS, Omega 3

Dietary Supplement Placebo

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

  • Other names: Control

Fish oil Experimental

Placebo Placebo Comparator

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
No Results Posted