Relapsing- Remitting Multiple Sclerosis
Conditions
Keywords
R-R MS
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).
Interventions
DIETARY_SUPPLEMENTFish 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.
DIETARY_SUPPLEMENTPlacebo
Orally, 4 Capsules per day, (glycerin, water purified, tocopherol, sunflower oil and titanium dioxide), during 12 months.
Sponsors
Coordinación de Investigación en Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TNF alpha | 3 months | Serum TNF alpha levels, at baseline, 3, 6, 9 and 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IL-1 beta, IL-6, Lipoperoxides, nitric oxide | 3 months | Serum IL-1 beta, IL-6, Lipoperoxides, nitric oxide levels at baseline, 3, 6, 9 and 12 months. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Expanded Disability Status Scale (EDSS) and Annualized rate of relapses (ARR) | 6 months | EDSS and ARR at baseline, 6 months and 12 months |
Countries
Mexico
Outcome results
None listed