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Double-Blind, Placebo-Controlled Trial of Vitamin E as Add-on Therapy for Children With Epilepsy
This study has been completed.
First Received: February 23, 2000   Last Updated: June 23, 2005   History of Changes
Sponsored by: National Center for Research Resources (NCRR)
Information provided by: National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier: NCT00004637
  Purpose

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 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.


Condition Intervention Phase
Epilepsy
Drug: Vitamin E
Phase IV

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy
MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: alpha-Tocopheryl acetate alpha-Tocopherol Vitamin E Tocopherols Tocotrienol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control
  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of intractable epilepsy, defined as 1) at least 4 seizures per month; 2) failure of at least 3 standard AEDs EEG within the last 6 months
  • Measurable seizure occurrence (parent/caregiver is able to count the number of seizures in any given time period)
  • Stable AED regimen, with at least one standard AED for at least 2 months prior to enrollment
  • No vitamin E supplementation (except as in standard multivitamin for age) for 6 months prior to study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004637

Locations
United States, Colorado
The Children's Hospital, Neurology B155
Denver, Colorado, United States, 80218
Sponsors and Collaborators
Investigators
Principal Investigator: Paul Levisohn, M.D.
  More Information

No publications provided

Study ID Numbers: NCRR-M01RR00069-0611, M01RR00069
Study First Received: February 23, 2000
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00004637     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Tocopherols
Tocopherol acetate
Vitamin E
Antioxidants
Epilepsy
Vitamins
Tocotrienols
Central Nervous System Diseases
Trace Elements
Micronutrients
Brain Diseases
Alpha-Tocopherol

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases
Brain Diseases
Protective Agents
Pharmacologic Actions
Vitamin E
Epilepsy
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on May 07, 2009