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NCT00004637 · ClinicalTrials.gov registry record · Phase 4
Double-Blind, Placebo-Controlled Trial of Vitamin E as Add-on Therapy for Children With Epilepsy
A Phase 4 study of Epilepsy, sponsored by National Center for Research Resources (NCRR).
- Completed
- Registry status
- Phase 4
- Development phase
- 1
- Study location
NCT00004637 is a Phase 4 study of Epilepsy that has completed, run by National Center for Research Resources (NCRR). The trial reports 1 study location across 1 state.
The verdict
NCT00004637, a Phase 4 study of Epilepsy, has completed, sponsored by National Center for Research Resources (NCRR).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1
- Study location
Study 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 E's usefulness and safety as a treatment for epilepsy. Fifty patients will be recruited from the Children's Epilepsy Program at The Children's 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 and/or alternative medicine they may use. The study is two phases. Study participants will be given either vitamin E or placebo (fake pill/liquid) 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 chan
Conditions Studied
Interventions
- DRUG Vitamin E
Study Locations (1)
Colorado
- The Children's Hospital, Neurology B155 - Denver
Trial Details
| Field | Value |
|---|---|
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00004637
The ClinicalTrials.gov registry entry for NCT00004637 describes a study currently listed as completed, categorized as Phase 4. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Center for Research Resources (NCRR), which has 94 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 1 intervention - of which Vitamin E is the first listed.
NCT00004637 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT00004637 about?
NCT00004637 is a clinical study titled "Double-Blind, Placebo-Controlled Trial of Vitamin E as Add-on Therapy for Children With Epilepsy". 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, ke...
What is the current status of trial NCT00004637?
This trial is currently completed. It is a Phase 4 study.
What conditions does trial NCT00004637 study?
This clinical trial studies the following conditions: Epilepsy.
What interventions are being tested in trial NCT00004637?
The interventions under investigation include: Vitamin E (DRUG).
Who is sponsoring clinical trial NCT00004637?
This trial is sponsored by National Center for Research Resources (NCRR), which has 94 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00004637 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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