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Ketogenic Diet Program for Epilepsy

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ClinicalTrials.gov Identifier: NCT02497105
Recruitment Status : Recruiting
First Posted : July 14, 2015
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will assess the effectiveness of the ketogenic diet (high-fat, low-carbohydrate, and moderate protein) in treating epilepsy. Two study groups will be comprised of children with epilepsy (0-18 years of age) and whether or not they receive the ketogenic diet - epilepsy/ketogenic diet and epilepsy/non-ketogenic diet.

Condition or disease Intervention/treatment
Epilepsy Other: Ketogenic Diet

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ketogenic Diet Program for Epilepsy
Study Start Date : January 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Epilepsy/Ketogenic Diet
Children (0-18 years of age) diagnosed with epilepsy will receive the ketogenic diet intervention.
Other: Ketogenic Diet
Dietary
No Intervention: Epilepsy/Non-Ketogenic Diet
Children (0-18 years of age) diagnosed with epilepsy will not receive the ketogenic diet intervention.


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in the core symptoms of epilepsy (seizure frequency/severity) [ Time Frame: Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet) ]
    Assess the number of epileptic seizures through review/analysis of responses to the seizure log (self-report)


Secondary Outcome Measures :
  1. Change from baseline in the number of medications used for epilepsy management [ Time Frame: Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet) ]
    Assess changes through the review/analysis of self-report and medical record data

  2. Change from baseline in the dosage of medications used for epilepsy management [ Time Frame: Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet) ]
    Assess changes through the review/analysis of self-report and medical record data

  3. Change from baseline in the number of lab tests ordered for epilepsy management [ Time Frame: Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet) ]
    Assess changes through the review/analysis of self-report and medical record data

  4. Change from baseline in the number of emergency room or hospital visits for epilepsy management [ Time Frame: Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet) ]
    Assess changes through the review/analysis of self-report and medical record data

  5. Change from baseline in subject/family satisfaction with the ketogenic diet [ Time Frame: Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet) ]
    Assess changes through the review/analysis of self-report and medical record data

  6. Change from baseline in ketone levels due to the ketogenic diet [ Time Frame: Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet) ]
    Assess ketone level differences and changes through the analysis of serum and urine

  7. Change from baseline in biochemical profiles due to the ketogenic diet [ Time Frame: Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet) ]
    Assess biochemical profile differences and changes through the analysis of blood and stool (gut microbiome) specimen samples


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 0-18 years.
  • Primary diagnosis of epilepsy.
  • Parent/legal guardian and child able to read or understand English, and able/willing to provide informed consent/assent.
  • Females of childbearing potential must have a negative pregnancy test result and agree to use a medically acceptable method of contraception throughout the entire study period and for 30 days after the last dose of study drug - childbearing potential is defined a girls who are > Tanner stage 2 and urine pregnancy tests are acceptable.

Exclusion Criteria:

  • Known cardiac disorder including arrhythmias or hypertension.
  • Carnitine deficiency (primary).
  • Carnitine palmitoyltransferase (CPT) I or II deficiency.
  • Carnitine translocase deficiency.
  • Beta-oxidation defects - medium-chain acyl dehydrogenase deficiency (MCAD), long-chain acyl dehydrogenase deficiency (LCAD), short-chain acyld dehydrogenase deficiency (SCAD), long-chain 3-hydroxyacyl-coenzyme A (CoA) deficiency, and medium-chain 3-hydroxyacyl-CoA deficiency.
  • Pyruvate carboxylase deficiency.
  • Porphyria.
  • Inability to maintain adequate nutrition.
  • Patient or caregiver non-compliance.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497105


Contacts
Contact: Miki Wong, RD 808-951-3726 mwong@shrinenet.org
Contact: Rob H Miyamoto, PhD 808-951-3693 rmiyamoto@shrinenet.org

Locations
United States, Hawaii
Shriners Hospitals for Children - Honolulu Recruiting
Honolulu, Hawaii, United States, 96826-1099
Contact: Miki Wong, RD    808-951-3726    mwong@shrinenet.org   
Contact: Rob H Miyamoto, PhD    808-951-3693    rmiyamoto@shrinenet.org   
Principal Investigator: Ryan W Lee, MD         
Sponsors and Collaborators
Shriners Hospitals for Children
University of Hawaii
Investigators
Principal Investigator: Ryan W Lee, MD Shriners Hospitals for Children - Honolulu
More Information

Publications:
http://www.aetna.com/cpb/medical/data/200_299/0226.html Clinical Policy Bulletin: Hospitalization for the Initiation of Ketogenic Diet for the Treatment of Intractable Seizures. Accessed November 14, 2013.
http://www.charliefoundation.org/offering-hope.html Accessed November 14, 2013

Responsible Party: Ryan Lee, MD, Director - Neurodevelopmental Clinic, Research, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT02497105     History of Changes
Other Study ID Numbers: HON1402
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Ryan Lee, MD, Shriners Hospitals for Children:
Epilepsy
Intractable Seizures
Ketogenic Diet
Biochemical Profiles

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases