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Dietary Supplement
Ketogenic Therapy for Epilepsy
N/A
Recruiting
Led By Peggy R. Borum, Ph.D.
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will help researchers understand how best to treat children with seizures that don't respond to available therapies.
Who is the study for?
This trial is for children with seizures not well-managed by current treatments. Participants must be prescribed a ketogenic diet by their doctor, able to process high fat and low carbohydrate diets according to lab tests, and willing to follow the therapy regimen and maintain records.Check my eligibility
What is being tested?
The study investigates how Ketogenic Therapy affects children with epilepsy. It aims to understand how this high-fat, low-carbohydrate diet works as a treatment and determine the most effective way of administering it.See study design
What are the potential side effects?
Potential side effects of Ketogenic Therapy may include digestive issues like constipation or diarrhea, changes in blood lipid levels, possible nutrient deficiencies, weight changes, and sometimes lethargy or irritability during initial adjustment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduced seizures
Secondary outcome measures
Pharmaceutical Preparations
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ketogenic TherapyExperimental Treatment1 Intervention
Ketogenic Therapy will be administered.
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,257 Total Patients Enrolled
3 Trials studying Seizures
673 Patients Enrolled for Seizures
Peggy R. Borum, Ph.D.Principal InvestigatorUniversity of Florida
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are following a diet called the ketogenic diet as prescribed by your doctor.Your lab tests show that your body cannot process a diet high in fat and low in carbohydrates.You have lab tests showing that your body can process a diet high in fat and low in carbohydrates.
Research Study Groups:
This trial has the following groups:- Group 1: Ketogenic Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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