---
title: Efficacy of Fish Oil in Multiple Sclerosis
nct_id: NCT01842191
overall_status: COMPLETED
phase: PHASE4
sponsor: Coordinación de Investigación en Salud, Mexico
study_type: INTERVENTIONAL
primary_condition: Relapsing- Remitting Multiple Sclerosis
countries: Mexico
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01842191.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01842191"
ct_last_update_post_date: 2013-05-22
last_seen_at: "2026-05-12T06:52:19.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy of Fish Oil in Multiple Sclerosis

**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

**NCT ID:** [NCT01842191](https://clinicaltrials.gov/study/NCT01842191)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** Coordinación de Investigación en Salud, Mexico
- **Conditions:** Relapsing- Remitting Multiple Sclerosis
- **Start Date:** 2010-05
- **Completion Date:** 2012-12
- **CT.gov Last Update:** 2013-05-22

## 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).

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **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
```

## Arms

- **Fish oil** (EXPERIMENTAL)
- **Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **Fish Oil** (DIETARY_SUPPLEMENT) — 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** (DIETARY_SUPPLEMENT) — Orally, 4 Capsules per day, (glycerin, water purified, tocopherol, sunflower oil and titanium dioxide), during 12 months.

## Primary Outcomes

- **TNF alpha** _(time frame: 3 months)_ — Serum TNF alpha levels, at baseline, 3, 6, 9 and 12 months.

## Secondary Outcomes

- **IL-1 beta, IL-6, Lipoperoxides, nitric oxide** _(time frame: 3 months)_

## Locations (1)

- IMSS, Specialties Hospital, Neurology Departament, Guadalajara, Jalisco, Mexico

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.imss, specialties hospital, neurology departament|guadalajara|jalisco|mexico` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01842191.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01842191*  
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