Clinical Trial of the Effects of DHA in the Treatment of Seizure Disorders - Full Text View

Purpose

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 It is typically withdrawn after 3 years.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.

Condition	Intervention	Phase
Epilepsy (Treatment Refractory)	Dietary Supplement: Fish Oil Other: Safflower Oil	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Double Blind Placebo Controlled Trial of Effects of DHA in Fish Oil for the Treatment of Seizure Disorders.

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Safflower oil Fish oil Liposyn

U.S. FDA Resources

Further study details as provided by The Canadian College of Naturopathic Medicine:

Primary Outcome Measures:

Seizure Diary [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Serum poly-unsaturated fatty acid levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Blood samples will be banked to allow for an assessment of change in blood levels of poly-unsaturated fatty acids between baseline and final study visit (6 months)
Serum anticonvulsant levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Blood samples will be assessed for levels of anti-convulsant medications at baseline, 3 month and 6 month time periods
Adverse reactions [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
All adverse reactions incurred by all participants within the study will be collected, reported and assessed by type, intensity, severity, duration, and relationship to the study products

Estimated Enrollment:	30
Study Start Date:	January 2013
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fish Oil Fish oil containing 1.5g of docosaexaenoic acid (DHA) consumed twice daily for a duration of 6 months	Dietary Supplement: Fish Oil Daily dose of fish oil standardized to contain 3g/day of DHA. The daily dose is divided; capsules are taken with meals for a period of 6 months. Other Name: Docosahexanoix acid
Placebo Comparator: Safflower Oil	Other: Safflower Oil Daily dose of 8g/day of safflower oil taken in divided doses as capsules and consumed with meals

Detailed Description:

This will be a small, double-blind study involving placebo and 3 g/day of DHA. There will be a one-month baseline period, followed by a six month treatment period. Placebo subjects will be offered DHA at the end of the treatment period, if they wish to take it.

Patients will primarily be nominated by the principle Investigator, Dr. Paul Hwang
Patients will be contacted by phone by the study coordinator, who will explain the study and ask about willingness to participate. Inclusion and exclusion criteria will be discussed, as well as the patient's responsibilities. It will be made clear that there will be no cost to the patient.
If patients are interested, a letter will be sent to them. The letter will contain a description of the study, the patient's responsibilities if he/she agrees to participate, and an explanation of informed consent.
One week after the letter, the study coordinator will again contact the patients by phone,, answer any questions, and

- if the patient is willing to participate - set up the initial (screening) visit.
At the screening visit (visit 1), the study coordinator will review the medial history (seizure frequency/type) and medications. The study coordinator will then give the subject written and verbal information. Patients will be asked to sign an informed consent form. They will be given a seizure diary, to keep during the first month (prior to treatment) and to continue for the six months of DHA treatment. The diary will record the frequency/type of seizures. (At this point, potential subjects will be sorted into placebo, and DHA groups, balanced for different types of seizure).
One month after visit 1, an appointment will be scheduled with Dr. Hwang, who will check the patient's health and order blood work related to anticonvulsant drug levels - which will be taken on that day (visit 2). About two teaspoons of extra blood will be taken and stored for possible future assays. The study coordinator will then provide the patients with their appropriate capsules for the first three months of the trial. The patient will receive written instructions on how to take the capsules. Only the study coordinator will know the patients' group assignments. (A sealed back-up of the code will be left with Dr. Burnham.) Patients will be given the study coordinator's cell phone number with instructions to call if they feel unwell at any time. If serious problems occur, the study coordinator will refer patients to the Emergency Department of the North York General Hospital.
One and two months after visit 2, the study coordinator will meet with the patients to check their well-being and progress, and to provide them with the next months' supply of capsules (visits 3 & 4).
One month later (visit 5), the patient will have another appointment with Dr. Hwang, who will check their health and progress, and order blood work. (Two teaspoons of the blood will be reserved for possible future assays.) The study coordinator will check the seizure diary and provide the next three month's supply of capsules.
One and two months later, the study coordinator will meet with the patients to check on their well-being and progress, and to provide them with their next months' supply of capsules (visits 6 & 7).
One month later, after the last month of the trial, another appointment will be booked with Dr. Hwang (visit 8) who will re-examine the patient, and schedule more blood work. (Two teaspoons of the blood will be reserved for possible future assays.) At the end of the visit, The study coordinator will debrief the patient and give him/her a letter of thanks from the P.I. The patient will then be told where he/she can purchase DHA if he/she wants to continue.
Data will be analyzed by Drs. Thompson and Burnham. After data analysis, patients will be informed about the results of the whole by letter.

Eligibility

Ages Eligible for Study:	15 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female, aged 15 years or older
Female subjects must be using a form of contraception
Three or more 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

Exclusion Criteria:

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 or fish oil
Cognitive impairment (I.Q. below 70) and/or inability to give informed consent.
Serious physical or mental health problems (in addition to seizures) or a progressive disorder
Failure to understand English
Subjects taking regular warfarin or aspirin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01769092

Contacts

Contact: Miles Thomson, PhD

epilepsypufastudy@gmail.com

Locations

Canada, Ontario
North York General Hospital	Recruiting
Toronto, Ontario, Canada, M2K 1E1
Principal Investigator: Paul H Hwang, MD
Sub-Investigator: Miles Thompson, PhD

Sponsors and Collaborators

The Canadian College of Naturopathic Medicine

North York General Hospital

Ontario Brain Institute

Investigators

Principal Investigator:	Paul A Hwang, MD	North York General Hospital
Study Director:	Mac Burnham, PhD	University of Toronto Epilepsy Research Program (UTERP)

More Information

No publications provided

Responsible Party:	The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier:	NCT01769092 History of Changes
Other Study ID Numbers:	CCNM1302
Study First Received:	January 14, 2013
Last Updated:	January 15, 2013
Health Authority:	Canada: Health Canada

Keywords provided by The Canadian College of Naturopathic Medicine:

Epilepsy
Seizure
Fish Oil

Additional relevant MeSH terms:

Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013