Atkins Plus KetoCal for Childhood Epilepsy

Completed · Phase 3

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT00681239

Run by

Johns Hopkins University

People needed

30

Starts

2008-05-01

Expected to finish

2009-12-01

Last updated by the study team

2009-12-31

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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