Epilepsy (Treatment Refractory)Phase 2/3NCT01769092
Clinical Trial of the Effects of DHA in the Treatment of Seizure Disorders
A Phase 2/3 study testing Fish Oil and Safflower Oil in people with Epilepsy (Treatment Refractory), run by The Canadian College of Naturopathic Medicine at 2 sites in Canada.
Trial 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 It is typically withdrawn after 3 years. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy (Treatment Refractory)
- What is being tested?
- Fish Oil and Safflower Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2013to Jan 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
North York General Hospital
Toronto, Ontario, M2K 1E1
Toronto Western Hospital
Toronto, Ontario
About this study
Official title: Double Blind Placebo Controlled Trial of Anticonvulsant Effects of n-3 PUFAs in Human Subjects With Epilepsy
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.
Read the 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.
- Neurologists from the North York General Hospital or Toronto Western Hospital will refer patients being treated for intractable epilepsy.
- 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 visit.
- At the initial visit, the study coordinator will 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 treatment. The diary will record the frequency/type of seizures. The study physician will review the medial history (seizure frequency/type), medications and blood work to be taken to measure serum levels of AEDs and n-3 PUFAs. 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 rest will be mailed. 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.
- Weekly telephone calls: Participants will receive scheduled weekly telephone calls from the study coordinator to collect any information recorded in the seizure diaries during the one month baseline period continuing through the sixth month treatment period.
- After the last month of the trial, a second in-person visit will be scheduled to re-examine the patient, and order 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 Dr. Burnham. After data analysis, patients will be informed about the results of the whole by letter.
- Conditions
- Epilepsy (Treatment Refractory)
- Being tested
- Fish Oil, Safflower Oil
- Keywords
- Epilepsy, Seizure, Fish Oil
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
Also called Docosahexanoic acid, EPA
The daily dose is divided; capsules are taken with meals for a period of 6 months.
Safflower OilOther
Daily dose of safflower oil taken in divided doses as capsules and consumed with meals.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Safflower Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Serum poly-unsaturated fatty acid levels
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)
Measured: 6 months
Serum anticonvulsant levels
Blood samples will be assessed for levels of anti-convulsant medications at baseline and 6 month time periods
Measured: 6 months
Adverse reactions
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2020
- Study completionJan 2020
Why it stopped: Unable to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy (Treatment Refractory)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Canadian College of Naturopathic Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- North York General Hospital, Ontario Brain Institute, University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- Paul A Hwang, MD, Principal investigator, North York General HospitalMac Burnham, PhD, Study director, University of Toronto Epilepsy Research Program (UTERP)Peter Carlen, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769092
- Sponsor's protocol ID
- CCNM1302
- Status last verified
- Feb 2023
- First submitted
- 14 Jan 2013
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Findings will be shared with participants upon request. Results will be disseminated at epilepsy conferences.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Placebo Controlled Trial of Anticonvulsant Effects of n-3 PUFAs in Human Subjects With Epilepsy
- ClinicalTrials.gov ID
- NCT01769092
- Acronym / sponsor ID
- CCNM1302
- Conditions
- Epilepsy (Treatment Refractory)
- Keywords
- Epilepsy, Seizure, Fish Oil
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit participants
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The Canadian College of Naturopathic MedicineUniversity, hospital or other
- Collaborators
- North York General Hospital, Ontario Brain Institute, University Health Network, Toronto
- Study start
- Jan 2013
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 16 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- Neurologists from the North York General Hospital or Toronto Western Hospital will refer patients being treated for intractable epilepsy.
- 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 visit.
- At the initial visit, the study coordinator will 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 treatment. The diary will record the frequency/type of seizures. The study physician will review the medial history (seizure frequency/type), medications and blood work to be taken to measure serum levels of AEDs and n-3 PUFAs. 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 rest will be mailed. 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.
- Weekly telephone calls: Participants will receive scheduled weekly telephone calls from the study coordinator to collect any information recorded in the seizure diaries during the one month baseline period continuing through the sixth month treatment period.
- After the last month of the trial, a second in-person visit will be scheduled to re-examine the patient, and order 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 Dr. Burnham. After data analysis, patients will be informed about the results of the whole by letter.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish Oil | Experimental | Dietary Supplement: Fish OilEach capsule contains 625 mg of fish oil (100 mg EPA \& 250 mg DHA). Participants will take 12 capsules per day over 6 months. |
| Safflower Oil | Placebo comparator | Other: Safflower OilEach capsule will contain 625 mg of Safflower oil. Participants will take 12 capsules per day over 6 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish OilAlso: Docosahexanoic acid, EPAThe daily dose is divided; capsules are taken with meals for a period of 6 months. | Dietary supplement | Fish Oil |
| Safflower OilDaily dose of safflower oil taken in divided doses as capsules and consumed with meals. | Other | Safflower Oil |
Primary outcome
Seizure Diary
Time frame: 6 months
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.
3 secondary outcomes
Serum poly-unsaturated fatty acid levels
Time frame: 6 months
Serum anticonvulsant levels
Time frame: 6 months
Adverse reactions
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Unable to recruit participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: Yes. Findings will be shared with participants upon request. Results will be disseminated at epilepsy conferences.
Related trials for Epilepsy (Treatment Refractory)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul A Hwang, MD principal investigator
North York General Hospital
Mac Burnham, PhD study director
University of Toronto Epilepsy Research Program (UTERP)
Peter Carlen, MD principal investigator
University Health Network, Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fish Oil and Safflower Oil in people with Epilepsy (Treatment Refractory), run by The Canadian College of Naturopathic Medicine at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure Diary (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.