Atkins Plus KetoCal for Childhood Epilepsy
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.
|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|
- Seizure reduction [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Ketosis [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Tolerability and taste [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2008|
|Study Completion Date:||December 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00681239
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Eric H Kossoff, MD||Johns Hopkins University|