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

NCT01769092 | Terminated Phase 2 DMC

• 1 other identifier: CCNM1302
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief 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 It is typically withdrawn after 3 years.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)

Keywords

Epilepsy; Seizure; Fish Oil

Outcome Measures

Primary Outcomes (1)

• Seizure Diary

  The primary outcome measure of the study will be a measure of the number of seizures each month as recorded in a seizure diary - a record kept under the supervision of the study coordinator.

  6 months

Secondary Outcomes (3)

• Serum poly-unsaturated fatty acid levels

  6 months

• Serum anticonvulsant levels

  6 months

• Adverse reactions

  6 months

Study Arms (2)

Fish Oil

EXPERIMENTAL

Each capsule contains 625 mg of fish oil (100 mg EPA \& 250 mg DHA). Participants will take 12 capsules per day over 6 months.

Dietary Supplement: Fish Oil

Safflower Oil

PLACEBO COMPARATOR

Each capsule will contain 625 mg of Safflower oil. Participants will take 12 capsules per day over 6 months.

Other: Safflower Oil

Interventions

Fish Oil DIETARY_SUPPLEMENT

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

Also known as: Docosahexanoic acid, EPA

Fish Oil

Safflower Oil OTHER

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

Safflower Oil

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged 18 years or older
• Female subjects must be using a form of contraception
• \>1 seizures per month
• EEG confirmation of seizure activity (no non-epileptic seizures)
• Agrees to comply with study procedures, and keep seizure diary
• Agrees not to make any major deviations from current diet (especially fish intake) or medications (type, dosage)
• Agrees to having portions of blood samples stored for assays
• Has given voluntary, written, informed consent to participate in the study

You may not qualify if:

• Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
• Use of significant amounts of fish oil or flax oil (omega-3) supplements within 8 weeks of the study.
• Allergy or sensitivity to fish, fish oil, coconut oil, olive oil, hemp oil, safflower oil, flax seed oil, or soybean oil
• Cognitive impairment (I.Q. below 70) and/or inability to give informed consent.
• Failure to understand English
• Subjects taking regular warfarin or aspirin

Sponsors & Collaborators

• The Canadian College of Naturopathic Medicine: lead
• North York General Hospital: collaborator
• Ontario Brain Institute: collaborator
• University Health Network, Toronto: collaborator

Study Sites (2)

North York General Hospital

Toronto, Ontario, M2K 1E1, Canada

Location

Toronto Western Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Fish Oils; Safflower Oil

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Paul A Hwang, MD

  North York General Hospital

  PRINCIPAL INVESTIGATOR

• Mac Burnham, PhD

  University of Toronto Epilepsy Research Program (UTERP)

  STUDY DIRECTOR

• Peter Carlen, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 16, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

CA (2)