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Atkins Plus KetoCal for Childhood Epilepsy

This study has been completed.
Sponsor:
Collaborator:
Nutricia, Inc.
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00681239
First received: May 19, 2008
Last updated: December 30, 2009
Last verified: December 2009
History of Changes
  Purpose

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 Intervention Phase
Epilepsy
 Dietary Supplement: Modified Atkins diet and KetoCal
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Seizure reduction [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ketosis [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Tolerability and taste [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: May 2008
Study Completion Date: December 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Eric Kossoff MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00681239     History of Changes
Other Study ID Numbers: NA_00017953
Study First Received: May 19, 2008
Last Updated: December 30, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
childhood
epilepsy
intractable
 seizures
Atkins
ketogenic

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

ClinicalTrials.gov processed this record on May 23, 2013