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CompletedNCT00181090Updated Mar 27, 2009

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

A Phase 1 interventional study of Modified Atkins diet in Epilepsy, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2009-03-27.

Sponsored by Johns Hopkins University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
3 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Epilepsy

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Keywords

  • Epilepsy
  • Ketosis
  • Atkins
  • seizures
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 30 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Ages 3-18
  • Daily seizures or 7 per week
  • Failed at least 2 anticonvulsants

Exclusion criteria

Exclusion Criteria:

  • Prior use of the Atkins diet for over 1 week
  • Significant heart, liver, or kidney disease
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants

Interventions

  • BehavioralModified Atkins diet
06

What researchers measure

Primary outcomes

  1. Seizure control

    Time frame: 6 months

  2. Ketosis

    Time frame: 6 months

Secondary outcomes

  1. Tolerability

    Time frame: 6 months

  2. Safety - cholesterol, kidney function, weight

    Time frame: 6 months

07

Study locations

1 site
  • Johns Hopkins Hospital
    Baltimore, Maryland 21287, United States
08

References and documents

Publications

  • 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. doi: 10.1212/01.wnl.0000098889.35155.72. PubMed 14694049 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00181090
Lead sponsor
Johns Hopkins University
First posted
Sep 16, 2005
Start date
Feb 2005
Completion
Sep 2006
Last update
Mar 27, 2009

Study contacts

Eric H Kossoff, MD
principal investigator · Johns Hopkins University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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