Completed

Vitamin E as Add-on Therapy for Uncontrolled Epilepsy in Children

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What is being tested

Vitamin E

Drug
Who is being recruted

Brain Diseases+1

+ Central Nervous System Diseases

+ Nervous System Diseases

From 1 to 18 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

NCT00004637
Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpilepsy

Criteria

4 inclusion criteria required to participate
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)

No vitamin E supplementation (except as in standard multivitamin for age) for 6 months prior to study entry

Stable AED regimen, with at least one standard AED for at least 2 months prior to enrollment

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
CompletedOne Study Center