NCT01744275

Brief Summary

This a multi-center study to examine whether supplementation with omega 3 fatty acids will reduce seizure frequency in patients with epilepsy .

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
370

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

February 27, 2014

Status Verified

February 1, 2014

Enrollment Period

1 year

First QC Date

December 4, 2012

Last Update Submit

February 25, 2014

Conditions

Epilepsy

Keywords

EpilepsyOmega 3 fatty acids

Outcome Measures

Primary Outcomes (1)

  • Seizure Frequency

    number of seizures during the treatment period

    18 months

Secondary Outcomes (5)

  • categorized seizure frequency

    18 months

  • Percentage of overall seizure frequency modification

    18 months

  • Time Free of seizures during treatment

    12 months

  • Reduction in seizure frequency

    12 months

  • Quality of Life

    12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: corn oil

Omega 3 fatty acids supplementation

EXPERIMENTAL

Omega 3 fatty acids capsules

Dietary Supplement: Omega 3 fatty acids

Interventions

Omega 3 fatty acidsDIETARY_SUPPLEMENT
Omega 3 fatty acids supplementation
corn oilDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with active Epilepsy

You may not qualify if:

  • pregnant women or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute, Hospital do Coração

São Paulo, São Paulo, 04005-909, Brazil

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Fatty Acids, Omega-3Corn Oil

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsFats, UnsaturatedPlant OilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • M J Carrion, MD

    Hospital do Coracao

    PRINCIPAL INVESTIGATOR

  • O Berwanger, PhD

    Hospital do Coracao

    STUDY CHAIR

  • R D Lopes, PhD

    BCRI

    STUDY CHAIR

  • F A Scorza, PhD

    Federal University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2012

First Posted

December 6, 2012

Study Start

July 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2016

Last Updated

February 27, 2014

Record last verified: 2014-02

Locations

BR(1)