RCT of the Efficacy of the Ketogenic Diet in the Treatment of Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2006-07-31

Brief Summary

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A study of the efficacy and tolerability of two different ketogenic diets in children with drug resistant epilepsy; children resistant to at least two drugs randomised to reveive diet after baseline or after further 3m control period; in addition randomised to either MCT or classical ketogenic diet.

Detailed Description

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Conditions

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Epilepsy

Keywords

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Ketogenic diet

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of epilepsy for at least 2 years, resistant to at least two AEDs, at least 7 seizures/week

Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Institute of Child Health

Principal Investigators

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Helen Cross, Professor

Role: PRINCIPAL_INVESTIGATOR

UCL Institute of Child Health

Locations

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Institute of Child Health, The Wolfson Centre

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Neal EG, Chaffe H, Schwartz RH, Lawson MS, Edwards N, Fitzsimmons G, Whitney A, Cross JH. The ketogenic diet for the treatment of childhood epilepsy: a randomised controlled trial. Lancet Neurol. 2008 Jun;7(6):500-6. doi: 10.1016/S1474-4422(08)70092-9. Epub 2008 May 2.

Reference Type DERIVED

PMID: 18456557 (View on PubMed)

Other Identifiers

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98NR04

Identifier Type: -

Identifier Source: org_study_id