NCT00564915

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2001

Longer than P75 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2007

Completed
Last Updated

November 29, 2007

Status Verified

November 1, 2007

First QC Date

November 28, 2007

Last Update Submit

November 28, 2007

Conditions

Epilepsy

Keywords

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Change in seizure frequency

    3 months

Secondary Outcomes (1)

  • Tolerability and assessment of ketosis and growth

    3 months

Interventions

Ketogenic dietDIETARY_SUPPLEMENT

Ketogenic diet

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Child Health, The Wolfson Centre

London, WC1N 1EH, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 18456557DERIVED

MeSH Terms

Conditions

Epilepsy

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Helen Cross, Professor

    UCL Institute of Child Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 28, 2007

First Posted

November 29, 2007

Study Start

December 1, 2001

Study Completion

July 1, 2006

Last Updated

November 29, 2007

Record last verified: 2007-11

Locations

GB(1)