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Double-blind, placebo-controlled trial of vitamin E as add-on therapy for children with epilepsy Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Double-blind, placebo-controlled trial of vitamin E as add-on therapy for children with epilepsy conditions. Clinical Trials Search.org is a website dedicated 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 medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including 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 permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes 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. Participants oftentimes recieve the finest healthcare available for their Double-blind, placebo-controlled trial of vitamin E as add-on therapy for children with epilepsy condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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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. Search for Genes Influencing Childhood Absence Epilepsy Study
2. Effect of Vigabatrin on Brain Blood Flow and Glucose Metabolism
3. Treatment Of Primary Generalized Tonic-Clonic Seizures With An Investigational New Drug
4. Measurement Of Serum Levels Of Two Antiepileptic Drugs During Conversion In Patients With Epilepsy.
5. Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy
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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