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Double-blind, placebo-controlled trial of vitamin E as add-on therapy for children with epilepsy Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Double-blind, placebo-controlled trial of vitamin E as add-on therapy for children with epilepsy conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Double-blind, placebo-controlled trial of vitamin E as add-on therapy for children with epilepsy Clinical research trials and Double-blind, placebo-controlled trial of vitamin E as add-on therapy for children with epilepsy health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Double-blind, placebo-controlled trial of vitamin E as add-on therapy for children with epilepsy. Double-blind, placebo-controlled trial of vitamin E as add-on therapy for children with epilepsy Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Double-blind, placebo-controlled trial of vitamin E as add-on therapy for children with epilepsy clinical trial. Subjects frequently get the best healthcare possible for their Double-blind, placebo-controlled trial of vitamin E as add-on therapy for children with epilepsy condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Double-blind, placebo-controlled trial of vitamin E as add-on therapy for children with epilepsy  Double-blind, placebo-controlled trial of vitamin E as add-on therapy for children with epilepsy
Double-blind, placebo-controlled trial of vitamin E as add-on therapy for children with epilepsy
For Condition: Epilepsy
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 1 Year/18 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulLevisohn, Principal Investigator,
The Children's Hospital, Neurology B155
Denver, Colorado, 80218
United States
Additional Information:
Study ID Numbers: NCRR-M01RR00069-0611; M01RR00069
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004637
Other Epilepsy Studies:
1. Early Surgical Intervention to Treat Epilepsy
2. Brain Blood Flow Studies of Language and Memory
3. Activating Effects of Sleep Deprivation on Synchronized MEG-EEG Recordings of Epilepsy Patients with Non-Diagnostic EEG
4. Multicenter trial for adults with partial seizures
5. Genetic Study of Familial Epilepsy
Related Studies:
Other Epilepsy Clinical Trials
Other Colorado Clinical Trials
Other Denver Clinical Trials
Double-blind, placebo-controlled trial of vitamin E as add-on therapy for children with epilepsy
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