Vitamin E as Add-on Therapy for Uncontrolled Epilepsy in Children
Vitamin E
Brain Diseases+1
+ Central Nervous System Diseases
+ Nervous System Diseases
Treatment Study
Summary
This study aims to find out if vitamin E can help children with epilepsy experience fewer seizures. Epilepsy is a condition that affects children, with about 20-30% not having their seizures well-controlled by standard medications. While there are other options like newer medications, a special diet, and surgery, not all patients are suitable for these. Hence, there's a need for additional treatments to improve seizure control. Previous studies in animals and some children have suggested that vitamin E might help reduce seizures, but more research is needed to confirm this. The study will involve 50 children from the Children's Epilepsy Program in Denver, Colorado, all of whom have a confirmed diagnosis of epilepsy that isn't well-controlled with standard medications. During the 6-month study, participants will either receive vitamin E or a placebo (a fake pill/liquid) in two phases, with the order decided by chance. Participants will take the liquid vitamin E or placebo twice a day, and both they and their doctors won't know who is taking vitamin E and who is taking the placebo. Participants will need to visit the hospital for 3 outpatient and 2 inpatient visits, where they'll fill out health-related quality of life questionnaires and have blood drawn. Throughout the study, participants will also keep a diary of their seizures. The study will only continue if the doctor believes it's best for the patient, and all other medications and therapies must remain constant throughout.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 1 to 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
The Children's Hospital, Neurology B155
Denver, United StatesOpen The Children's Hospital, Neurology B155 in Google Maps