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Trial record 9 of 1405 for:    Epilepsy

Ketogenic Diet Program for Epilepsy

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Shriners Hospitals for Children
Sponsor:
Collaborator:
University of Hawaii
Information provided by (Responsible Party):
Ryan Lee, MD, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT02497105
First received: July 9, 2015
Last updated: April 12, 2016
Last verified: April 2016
  Purpose
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 Intervention
Epilepsy
Other: Ketogenic Diet

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ketogenic Diet Program for Epilepsy

Resource links provided by NLM:


Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Assess the number of epileptic seizures through review/analysis of responses to the seizure log (self-report)


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Assess changes through the review/analysis of self-report and medical record data

  • 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) ] [ Designated as safety issue: No ]
    Assess changes through the review/analysis of self-report and medical record data

  • 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) ] [ Designated as safety issue: No ]
    Assess changes through the review/analysis of self-report and medical record data

  • 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) ] [ Designated as safety issue: No ]
    Assess changes through the review/analysis of self-report and medical record data

  • 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) ] [ Designated as safety issue: No ]
    Assess changes through the review/analysis of self-report and medical record data

  • 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) ] [ Designated as safety issue: No ]
    Assess ketone level differences and changes through the analysis of serum and urine

  • 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) ] [ Designated as safety issue: No ]
    Assess biochemical profile differences and changes through the analysis of blood and stool (gut microbiome) specimen samples


Estimated Enrollment: 30
Study Start Date: January 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: July 9, 2015
Last Updated: April 12, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by 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

ClinicalTrials.gov processed this record on December 09, 2016