Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT01769092
Eligibility Criteria:
Inclusion Criteria:
* 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
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, 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01769092
Study Brief:
Protocol Section:
NCT01769092