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Clinical Trial of the Effects of DHA in the Treatment of Seizure Disorders

NCT01769092 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-02-10

No results posted yet for this study

Summary

For many years, there has been interest in the question of whether a special diet of some sort could be used to help control epileptic seizures. The ketogenic diet has been used since the 1920s, but it is used only in children, and is nutritionally unbalanced. It is typically withdrawn after 3 years. The ketogenic diet unfortunately, offers no long-term solution to seizure control.

Our preliminary research now suggests that there may be a healthy, long-term dietary approach to controlling seizures.

Based on our animal work and published clinical studies the investigators hypothesize that a DHA dose of 3 g/day will reduce seizure frequency in patients with intractable seizures.

Conditions

  • Epilepsy (Treatment Refractory)

Interventions

DIETARY_SUPPLEMENT

Fish Oil

The daily dose is divided; capsules are taken with meals for a period of 6 months.

OTHER

Safflower Oil

Daily dose of safflower oil taken in divided doses as capsules and consumed with meals.

Sponsors & Collaborators

  • North York General Hospital

    collaborator OTHER

  • Ontario Brain Institute

    collaborator OTHER

  • University Health Network, Toronto

    collaborator OTHER

  • The Canadian College of Naturopathic Medicine

    lead OTHER

Principal Investigators

  • Paul A Hwang, MD · North York General Hospital

  • Mac Burnham, PhD · University of Toronto Epilepsy Research Program (UTERP)

  • Peter Carlen, MD · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01769092 on ClinicalTrials.gov