Completed

Efficacy of the Ketogenic Diet -- a Blinded Study

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What is being tested

Ketogenic diet

Behavioral
Who is being recruted

Epileptic Syndromes+9

+ Brain Diseases

+ Central Nervous System Diseases

From 1 to 10 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 1997
See protocol details

Summary

Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: December 22, 2006
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 1997

Actual date on which the first participant was enrolled.

The ketogenic diet (KD) is a form of therapy for seizures that involves a brief period of fasting followed by a very carefully controlled high fat-low protein and carbohydrate diet. Studies suggest it is useful in children whose seizures could not be controlled by any of the medicines available. This study is designed to test, in a carefully controlled fashion, how well the diet works in children with "drop" seizures. Children who experience 15 or more drop seizures each day, despite having used at least two medications, may be eligible to participate. This study requires children to undergo periods of fasting and to maintain a carefully controlled diet. Parents of participating children monitor their children's diets and keep daily meal and seizure diaries.

Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: December 22, 2006
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 10 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

Epileptic SyndromesBrain DiseasesCentral Nervous System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGenetic Diseases, InbornEpilepsySeizuresLennox Gastaut Syndrome

Criteria

2 inclusion criteria required to participate
15 myoclonic or atonic seizures a day

EEG with Lennox-Gastaut pattern

3 exclusion criteria prevent from participating
15 atonic or myoclonic seizures a day

on > 3 medications

previously on diet and/or evidence of metabolic disorder

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

Johns Hopkins Hospital

Baltimore, United StatesOpen Johns Hopkins Hospital in Google Maps
CompletedOne Study Center