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Modified Atkins Diet Plus KetoCal for Adult Epilepsy

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Johns Hopkins University
Sponsor:
Collaborator:
Nutricia Liverpool
Information provided by (Responsible Party):
Mackenzie Cervenka, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01834482
First received: April 1, 2013
Last updated: February 17, 2015
Last verified: February 2015
History of Changes
  Purpose

The modified Atkins diet (MAD) has been shown to be effective in treating children and adults with medically resistant seizures. A recent study in children showed that the use of KetoCal® once per day in addition to the MAD appeared to be beneficial when used during the first month. The investigators hypothesize that including a daily KetoCal® liquid tetrapak with one meal during the initial month of the MAD will produce urinary ketosis in more adult patients than the MAD alone and will lead to greater seizure reduction.


Condition Intervention Phase
Epilepsy
Seizure
Medically Resistant Epilepsy
Medically Resistant Seizures
 Dietary Supplement: Modified Atkins diet
Dietary Supplement: KetoCal
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Evaluation of KetoCal® in Initial Combination With the Modified Atkins Diet for the Dietary Management of Intractable Adult Epilepsy.

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Ketosis [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Time to urinary ketosis in days will be recorded and whether or not patients achieve serum ketosis at 1 month and 2 months.


Secondary Outcome Measures:
  • Seizure reduction [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    The percent seizure reduction compared to baseline (1 month before beginning the diet) will be recorded at 1 month and 2 months.

  • Tolerability and taste [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Patients will be asked to rank convenience, taste, texture, and tolerability of the liquid on a 10 point scale (1 = poor, 10 = excellent).

  • Side effects [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    Patients will be screened for constipation and asked if they have experienced any side effects related to use of the modified Atkins diet and KetoCal® at 1 and 2 months.

  • Study completion rate [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 80
Study Start Date: March 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Modified Atkins diet plus KetoCal
Patients will receive the modified Atkins diet in combination with a KetoCal tetrapak daily for the first month. The second month, no tetrapaks will be given.
 Dietary Supplement: Modified Atkins diet
Patients will receive the modified Atkins diet with a 20 gram per day carbohydrate limit and encouragement to consume plenty of fat and eat to satiety.
Dietary Supplement: KetoCal
Patients will receive a KetoCal 4:1 ratio (fat: carbohydrates and protein) liquid daily for the first month (if randomized to this arm of the study). They will also be started on the modified Atkins diet.
Other Names:
  • KetoCal 4:1 liquid
  • KetoCal tetrapak
Active Comparator: Modified Atkins diet
Patients will receive the modified Atkins diet for the first month. The second month, they will be given the choice to also use KetoCal in addition to the modified Atkins diet if they choose to do so.
 Dietary Supplement: Modified Atkins diet
Patients will receive the modified Atkins diet with a 20 gram per day carbohydrate limit and encouragement to consume plenty of fat and eat to satiety.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults ages >17 years.
  • At least weekly seizures (or 4 per month). All seizure types allowed.
  • Tried at least two anticonvulsants.

Exclusion Criteria:

  • Unwilling to restrict carbohydrates
  • Significantly underweight (Body Mass Index <18.5)
  • Prior use of the modified Atkins diet for ≥ 2 days
  • Prior use of KetoCal® at any time for any duration
  • Use of the ketogenic diet within the past year
  • Kidney disease
  • History of hypercholesterolemia (total cholesterol > 300 mg/dl) or hypertriglyceridemia (triglycerides > 200 mg/dl)
  • Metabolic or mitochondrial disorder
  • Pregnancy or breastfeeding
  • Lactose intolerance or milk allergy
  • Aversion to liquids or inability to eat solid food
  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: NCT01834482

Contacts
Contact: Mackenzie C. Cervenka, M.D. 443-287-0423 ext 3 mcerven1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Mackenzie C. Cervenka, M.D.    443-287-0423 ext 3    mcerven1@jhmi.edu   
Principal Investigator: Mackenzie C. Cervenka, M.D.         
Sub-Investigator: Eric H. Kossoff, M.D.         
Sub-Investigator: Bobbie Henry, R.D.         
Sponsors and Collaborators
Johns Hopkins University
Nutricia Liverpool
Investigators
Principal Investigator: Mackenzie C. Cervenka, M.D. Johns Hopkins University
  More Information

Additional Information:
KetoCal 4:1 liquid (tetrapaks)  This link exits the ClinicalTrials.gov site
Adult Epilepsy Diet Center at Hopkins website  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Mackenzie Cervenka, Assistant Professor of Neurology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01834482     History of Changes
Other Study ID Numbers: NA_00068726
Study First Received: April 1, 2013
Last Updated: February 17, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
seizures
epilepsy
adult
intractable
 medically refractory
Atkins
ketogenic
diet

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on March 03, 2015