NCT00181090

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

March 27, 2009

Status Verified

March 1, 2009

First QC Date

September 10, 2005

Last Update Submit

March 26, 2009

Conditions

Epilepsy

Keywords

EpilepsyKetosisAtkinsseizures

Outcome Measures

Primary Outcomes (2)

  • Seizure control

    6 months

  • Ketosis

    6 months

Secondary Outcomes (2)

  • Tolerability

    6 months

  • Safety - cholesterol, kidney function, weight

    6 months

Interventions

Modified Atkins dietBEHAVIORAL

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related 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. doi: 10.1212/01.wnl.0000098889.35155.72.

    PMID: 14694049BACKGROUND

Related Links

MeSH Terms

Conditions

EpilepsyKetosisSeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eric H Kossoff, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 16, 2005

Study Start

February 1, 2005

Study Completion

September 1, 2006

Last Updated

March 27, 2009

Record last verified: 2009-03

Locations

US(1)