Ketogenic Diet Program for Epilepsy

NCT02497105 | Completed DMC

• 1 other identifier: HON1402
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

Epilepsy; Intractable Seizures; Ketogenic Diet; Biochemical Profiles

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the core symptoms of epilepsy (seizure frequency/severity)

  Assess the number of epileptic seizures through review/analysis of responses to the seizure log (self-report)

  Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet)

Secondary Outcomes (7)

• Change from baseline in the number of medications used for epilepsy management

  Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet)

• Change from baseline in the dosage of medications used for epilepsy management

  Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet)

• Change from baseline in the number of lab tests ordered for epilepsy management

  Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet)

• Change from baseline in the number of emergency room or hospital visits for epilepsy management

  Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet)

• Change from baseline in subject/family satisfaction with the ketogenic diet

  Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet)

Study Arms (2)

Epilepsy/Ketogenic Diet

EXPERIMENTAL

Children (0-18 years of age) diagnosed with epilepsy will receive the ketogenic diet intervention.

Other: Ketogenic Diet

Epilepsy/Non-Ketogenic Diet

NO INTERVENTION

Children (0-18 years of age) diagnosed with epilepsy will not receive the ketogenic diet intervention.

Interventions

Ketogenic Diet OTHER

Dietary

Epilepsy/Ketogenic Diet

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shriners Hospitals for Children: lead
• University of Hawaii: collaborator

Study Sites (1)

Shriners Hospitals for Children - Honolulu

Honolulu, Hawaii, 96826-1099, United States

Location

Related Publications (19)

• 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.

  BACKGROUND

• Cervenka MC, Kossoff EH. Dietary treatment of intractable epilepsy. Continuum (Minneap Minn). 2013 Jun;19(3 Epilepsy):756-66. doi: 10.1212/01.CON.0000431396.23852.56.

  PMID: 23739109 BACKGROUND

• National Clinical Guideline Centre (UK). The Epilepsies: The Diagnosis and Management of the Epilepsies in Adults and Children in Primary and Secondary Care: Pharmacological Update of Clinical Guideline 20. London: Royal College of Physicians (UK); 2012 Jan. Available from http://www.ncbi.nlm.nih.gov/books/NBK247130/

  PMID: 25340221 BACKGROUND

• http://www.charliefoundation.org/offering-hope.html Accessed November 14, 2013

  BACKGROUND

• Lee PR, Kossoff EH. Dietary treatments for epilepsy: management guidelines for the general practitioner. Epilepsy Behav. 2011 Jun;21(2):115-21. doi: 10.1016/j.yebeh.2011.03.008. Epub 2011 Apr 21.

  PMID: 21514240 BACKGROUND

• Williams E, Abrahams J, Maguire A, Harris G. A parent's perspective on dietary treatments for epilepsy. Epilepsy Res. 2012 Jul;100(3):338-43. doi: 10.1016/j.eplepsyres.2011.09.024. Epub 2012 May 8.

  PMID: 22575229 BACKGROUND

• Kossoff EH, Caraballo RH, du Toit T, Kim HD, MacKay MT, Nathan JK, Philip SG. Dietary therapies: a worldwide phenomenon. Epilepsy Res. 2012 Jul;100(3):205-9. doi: 10.1016/j.eplepsyres.2011.05.024.

  PMID: 21856128 BACKGROUND

• Gilbert DL, Pyzik PL, Vining EP, Freeman JM. Medication cost reduction in children on the ketogenic diet: data from a prospective study. J Child Neurol. 1999 Jul;14(7):469-71. doi: 10.1177/088307389901400712.

  PMID: 10573471 BACKGROUND

• Mandel A, Ballew M, Pina-Garza JE, Stalmasek V, Clemens LH. Medical costs are reduced when children with intractable epilepsy are successfully treated with the ketogenic diet. J Am Diet Assoc. 2002 Mar;102(3):396-8. doi: 10.1016/s0002-8223(02)90091-x.

  PMID: 11902372 BACKGROUND

• Vining EP, Freeman JM, Ballaban-Gil K, Camfield CS, Camfield PR, Holmes GL, Shinnar S, Shuman R, Trevathan E, Wheless JW. A multicenter study of the efficacy of the ketogenic diet. Arch Neurol. 1998 Nov;55(11):1433-7. doi: 10.1001/archneur.55.11.1433.

  PMID: 9823827 BACKGROUND

• Freeman JM, Vining EP, Pillas DJ, Pyzik PL, Casey JC, Kelly LM. The efficacy of the ketogenic diet-1998: a prospective evaluation of intervention in 150 children. Pediatrics. 1998 Dec;102(6):1358-63. doi: 10.1542/peds.102.6.1358.

  PMID: 9832569 BACKGROUND

• Neal EG, Chaffe H, Schwartz RH, Lawson MS, Edwards N, Fitzsimmons G, Whitney A, Cross JH. The ketogenic diet for the treatment of childhood epilepsy: a randomised controlled trial. Lancet Neurol. 2008 Jun;7(6):500-6. doi: 10.1016/S1474-4422(08)70092-9. Epub 2008 May 2.

  PMID: 18456557 BACKGROUND

• Henderson CB, Filloux FM, Alder SC, Lyon JL, Caplin DA. Efficacy of the ketogenic diet as a treatment option for epilepsy: meta-analysis. J Child Neurol. 2006 Mar;21(3):193-8. doi: 10.2310/7010.2006.00044.

  PMID: 16901419 BACKGROUND

• Beghi E, Frigeni B, Beghi M, De Compadri P, Garattini L. A review of the costs of managing childhood epilepsy. Pharmacoeconomics. 2005;23(1):27-45. doi: 10.2165/00019053-200523010-00003.

  PMID: 15693726 BACKGROUND

• de Kinderen RJ, Lambrechts DA, Postulart D, Kessels AG, Hendriksen JG, Aldenkamp AP, Evers SM, Majoie MH. Research into the (Cost-) effectiveness of the ketogenic diet among children and adolescents with intractable epilepsy: design of a randomized controlled trial. BMC Neurol. 2011 Jan 25;11:10. doi: 10.1186/1471-2377-11-10.

  PMID: 21262002 BACKGROUND

• Herbert MR, Buckley JA. Autism and dietary therapy: case report and review of the literature. J Child Neurol. 2013 Aug;28(8):975-82. doi: 10.1177/0883073813488668. Epub 2013 May 10.

  PMID: 23666039 BACKGROUND

• De Angelis M, Piccolo M, Vannini L, Siragusa S, De Giacomo A, Serrazzanetti DI, Cristofori F, Guerzoni ME, Gobbetti M, Francavilla R. Fecal microbiota and metabolome of children with autism and pervasive developmental disorder not otherwise specified. PLoS One. 2013 Oct 9;8(10):e76993. doi: 10.1371/journal.pone.0076993. eCollection 2013.

  PMID: 24130822 BACKGROUND

• Kossoff EH, Zupec-Kania BA, Amark PE, Ballaban-Gil KR, Christina Bergqvist AG, Blackford R, Buchhalter JR, Caraballo RH, Helen Cross J, Dahlin MG, Donner EJ, Klepper J, Jehle RS, Kim HD, Christiana Liu YM, Nation J, Nordli DR Jr, Pfeifer HH, Rho JM, Stafstrom CE, Thiele EA, Turner Z, Wirrell EC, Wheless JW, Veggiotti P, Vining EP; Charlie Foundation, Practice Committee of the Child Neurology Society; Practice Committee of the Child Neurology Society; International Ketogenic Diet Study Group. Optimal clinical management of children receiving the ketogenic diet: recommendations of the International Ketogenic Diet Study Group. Epilepsia. 2009 Feb;50(2):304-17. doi: 10.1111/j.1528-1167.2008.01765.x. Epub 2008 Sep 23.

  PMID: 18823325 BACKGROUND

• Milani C, Hevia A, Foroni E, Duranti S, Turroni F, Lugli GA, Sanchez B, Martin R, Gueimonde M, van Sinderen D, Margolles A, Ventura M. Assessing the fecal microbiota: an optimized ion torrent 16S rRNA gene-based analysis protocol. PLoS One. 2013 Jul 15;8(7):e68739. doi: 10.1371/journal.pone.0068739. Print 2013.

  PMID: 23869230 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Ryan W Lee, MD

  Shriners Hospitals for Children, Honolulu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director - Neurodevelopmental Clinic, Research

Study Record Dates

• First Submitted: July 9, 2015
• First Posted: July 14, 2015
• Study Start: January 1, 2015
• Primary Completion: January 19, 2018
• Study Completion: January 19, 2018
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)