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NCT00181090 Clinical Trial

Use of the Atkins Diet for Children With Intractable Epilepsy: A Comparison of Daily Carbohydrate Limits

Epilepsy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00181090
Other study ID # 05-01-26-05
Secondary ID
Status Completed
Phase Phase 1
First received September 10, 2005
Last updated March 26, 2009
Start date February 2005
Est. completion date September 2006

Study information
Verified date March 2009
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study is designed to further investigate the use of a modified Atkins diet for children with intractable, daily seizures. It is a follow-up to a study recently completed by our institution. In this 6-month study, children will be randomized to either 10 or 20 grams of carbohydrate per day, then crossed over to the opposite amount at 3 months.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 18 Years
Eligibility Inclusion Criteria:

- Ages 3-18

- Daily seizures or 7 per week

- Failed at least 2 anticonvulsants

Exclusion Criteria:

- Prior use of the Atkins diet for over 1 week

- Significant heart, liver, or kidney disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Modified Atkins diet

Locations
Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kossoff EH, Krauss GL, McGrogan JR, Freeman JM. Efficacy of the Atkins diet as therapy for intractable epilepsy. Neurology. 2003 Dec 23;61(12):1789-91. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Seizure control 6 months No
Primary Ketosis 6 months No
Secondary Tolerability 6 months Yes
Secondary Safety - cholesterol, kidney function, weight 6 months Yes
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