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Efficacy of Fish Oil in Multiple Sclerosis (EFOMS)

Primary Purpose

Relapsing- Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Fish Oil
Placebo
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing- Remitting Multiple Sclerosis focused on measuring R-R MS

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IMSS, Specialties Hospital, Neurology Departament

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fish oil

Placebo

Arm Description

Outcomes

Primary Outcome Measures

TNF alpha
Serum TNF alpha levels, at baseline, 3, 6, 9 and 12 months.

Secondary Outcome Measures

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.

Full Information

First Posted
April 25, 2013
Last Updated
May 20, 2013
Sponsor
Coordinación de Investigación en Salud, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT01842191
Brief Title
Efficacy of Fish Oil in Multiple Sclerosis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing- Remitting Multiple Sclerosis
Keywords
R-R MS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fish oil
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish Oil
Other Intervention Name(s)
PUFAS, Omega 3
Intervention Description
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
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control
Intervention Description
Orally, 4 Capsules per day, (glycerin, water purified, tocopherol, sunflower oil and titanium dioxide), during 12 months.
Primary Outcome Measure Information:
Title
TNF alpha
Description
Serum TNF alpha levels, at baseline, 3, 6, 9 and 12 months.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
IL-1 beta, IL-6, Lipoperoxides, nitric oxide
Description
Serum IL-1 beta, IL-6, Lipoperoxides, nitric oxide levels at baseline, 3, 6, 9 and 12 months.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Expanded Disability Status Scale (EDSS) and Annualized rate of relapses (ARR)
Description
EDSS and ARR at baseline, 6 months and 12 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Genaro G Ortiz, phD
Organizational Affiliation
Social Security Mexican Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
IMSS, Specialties Hospital, Neurology Departament
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
19242067
Citation
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.
Results Reference
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Efficacy of Fish Oil in Multiple Sclerosis

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