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Atkins Plus KetoCal for Childhood Epilepsy

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ClinicalTrials.gov Identifier: NCT00681239
Recruitment Status : Completed
First Posted : May 21, 2008
Last Update Posted : December 31, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
The modified Atkins diet (MAD) is a relatively new, alternative dietary therapy for intractable childhood and adult epilepsy. Recent evidence suggests that a strict, highly ketotic, first month may be advantageous to both immediate and long-term efficacy. KetoCal® is a pre-mixed powder that can be used to create a 4:1 ketogenic diet shake as a meal substitute. The investigators hypothesize that substituting KetoCal® for a lunch during the initial month of the MAD will lead to improved seizure reduction over the MAD alone, as well as improved tolerability and lipid values.

Condition or disease Intervention/treatment Phase
Epilepsy Dietary Supplement: Modified Atkins diet and KetoCal Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Evaluation of KetoCal in Initial Combination With the Modified Atkins Diet for the Treatment of Intractable Childhood Epilepsy
Study Start Date : May 2008
Primary Completion Date : July 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
Patients will receive the modified Atkins diet in combination with a 10 oz KetoCal shake for the first month. The second month no shake will be given. Results at 1 month will be compared to 2 months, as well as to historical controls with the modified Atkins diet.
Dietary Supplement: Modified Atkins diet and KetoCal
10 gram per day Modified Atkins diet and 10 oz per day of KetoCal shake.
Other Name: KetoCal


Outcome Measures

Primary Outcome Measures :
  1. Seizure reduction [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Ketosis [ Time Frame: 2 months ]
  2. Tolerability and taste [ Time Frame: 2 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children ages 3-17 years
  • At least daily seizures (or 7 per week). All seizure types allowed
  • Tried at least two anticonvulsants

Exclusion Criteria:

  • Unwilling to restrict carbohydrates
  • Significantly underweight (BMI ≤ 5%)
  • Prior use of the modified Atkins diet for ≥ 2 days
  • Prior use of KetoCal® at any time for any duration
  • Use of the KD within the past year
  • Kidney disease
  • History of hypercholesterolemia(>300 mg/dl) or hypertriglyceridemia (>200 mg/dl)
  • Metabolic or mitochondrial disorder
  • Aversion to shakes or inability to eat solid food
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): NCT00681239


Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Nutricia, Inc.
Investigators
Principal Investigator: Eric H Kossoff, MD Johns Hopkins University