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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00181090 |
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Date of registration:
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10/09/2005 |
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Primary sponsor: |
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Public title:
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Use of the Atkins Diet for Children With Intractable Epilepsy: A Comparison of Daily Carbohydrate Limits
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Scientific title:
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Date of first enrolment:
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February 2005 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00181090 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Eric H Kossoff, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins University |
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Key inclusion & exclusion criteria
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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
Age minimum:
3 Years
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Epilepsy
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Intervention(s)
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Behavioral: Modified Atkins diet
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Primary Outcome(s)
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Ketosis
[Time Frame: 6 months]
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Seizure control
[Time Frame: 6 months]
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Secondary Outcome(s)
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Safety - cholesterol, kidney function, weight
[Time Frame: 6 months]
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Tolerability
[Time Frame: 6 months]
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Secondary ID(s)
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05-01-26-05
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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