Status:
COMPLETED
Atkins Plus KetoCal for Childhood Epilepsy
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Nutricia, Inc.
Conditions:
Epilepsy
Eligibility:
All Genders
3-17 years
Phase:
PHASE3
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...
Detailed Description
The modified Atkins diet (MAD) is a treatment for intractable epilepsy that has been used in over 100 children and adults worldwide since 2002. It mimics the ketotic state of the ketogenic diet (KD), ...
Eligibility Criteria
Inclusion
- Children ages 3-17 years
- At least daily seizures (or 7 per week). All seizure types allowed
- Tried at least two anticonvulsants
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00681239
Start Date
May 1 2008
End Date
December 1 2009
Last Update
December 31 2009
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287