Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004637
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-23
Brief Title:
Double-Blind Placebo-Controlled Trial of Vitamin E as Add-on Therapy for Children With Epilepsy
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2003-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study to see if vitamin E helps children with epilepsy have fewer seizures About 20-30 of children with epilepsy do not have adequate seizure control with established antiepileptic drugs AEDs Other options for patients with uncontrolled epilepsy are newer antiepileptic medications ketogenic diet and surgery However a small percentage of patients are candidates for these options Therefore additional treatments are needed to improve seizure control in patients with uncontrolled epilepsy Animal studies have shown an association between vitamin E supplementation and seizure reduction A study in children also showed that vitamin E helped reduce seizures However a similar study in adults did not show a reduction in seizures with vitamin E supplementation Therefore this research study is being done to help define vitamin Es usefulness and safety as a treatment for epilepsy Fifty patients will be recruited from the Childrens Epilepsy Program at The Childrens Hospital in Denver Colorado Qualifying patients will have a confirmed diagnosis of epilepsy that is currently uncontrolled with standard AEDs The study period is 6 months and includes the following Baseline period 1 month Arm I 2 months Wash-out period 1 month and Arm II 2 months Patients must have been on the same AEDs for 2 months before enrollment All medications and complementary therapies must remain constant throughout the study If at any point the physician feels it is not best for the patient to continue the study they will be discontinued Before the study starts study participants will be asked about seizure activity what they eat and about any complementary andor alternative medicine they may use The study is two phases Study participants will be given either vitamin E or placebo fake pillliquid in each phase of the study They will receive both vitamin E and placebo during the study Which phase they receive vitamin E and placebo will be decided by chance similar to rolling dice Study participants will take liquid vitamin E or placebo two times per day The study participants and study doctors will not know who is taking vitamin E and who is taking placebo Study participants will come to the hospital for 3 outpatient and 2 inpatient visits Health-related quality of life questionnaires will be filled out and blood will be drawn at three of the visits Seizure diaries will be maintained throughout the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| M01RR000069 | NIH | None | httpsreporternihgovquickSearchM01RR000069 |