Atkins Plus KetoCal for Childhood Epilepsy

NCT00681239 | Completed Phase 3

• 1 other identifier: NA_00017953
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

childhood; epilepsy; intractable; seizures; Atkins; ketogenic

Outcome Measures

Primary Outcomes (1)

• Seizure reduction

  2 months

Secondary Outcomes (2)

• Ketosis

  2 months

• Tolerability and taste

  2 months

Study Arms (1)

A

EXPERIMENTAL

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

Interventions

Modified Atkins diet and KetoCal DIETARY_SUPPLEMENT

10 gram per day Modified Atkins diet and 10 oz per day of KetoCal shake.

Also known as: KetoCal

A

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Nutricia, Inc.: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (3)

• Kossoff EH, Laux LC, Blackford R, Morrison PF, Pyzik PL, Hamdy RM, Turner Z, Nordli DR Jr. When do seizures usually improve with the ketogenic diet? Epilepsia. 2008 Feb;49(2):329-33. doi: 10.1111/j.1528-1167.2007.01417.x. Epub 2007 Nov 19.

  PMID: 18028405 BACKGROUND

• Kossoff EH, Turner Z, Bluml RM, Pyzik PL, Vining EP. A randomized, crossover comparison of daily carbohydrate limits using the modified Atkins diet. Epilepsy Behav. 2007 May;10(3):432-6. doi: 10.1016/j.yebeh.2007.01.012. Epub 2007 Feb 26.

  PMID: 17324628 BACKGROUND

• Kossoff EH, McGrogan JR, Bluml RM, Pillas DJ, Rubenstein JE, Vining EP. A modified Atkins diet is effective for the treatment of intractable pediatric epilepsy. Epilepsia. 2006 Feb;47(2):421-4. doi: 10.1111/j.1528-1167.2006.00438.x.

  PMID: 16499770 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric H Kossoff, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 19, 2008
• First Posted: May 21, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 31, 2009

Record last verified: 2009-12

Locations

US (1)