Short-term Ketogenic Diet as Compared With Conventional L... | NCT00968136

Studies
Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study

NCT00968136

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Aug 28, 2009Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Infantile Spasms

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 27, 2009

First Submission Date that Met QC Criteria

Aug 27, 2009

First Posted Date

Aug 28, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2009

Last Update Posted Date

Aug 28, 2009Estimated

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary outcome measures include seizure relapse and frequency after successful completion of the ketogenic diet.		Finally, 35 patients could be followed up for more than 12 months after successful discontinuation of the diet and then primary outcome will be measured.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients, who have recalcitrant infantile spasms and undertake the ketogenic diet at Severance Hospital and Sanggye Paik Hospital from 2005 to 2008.
Clinical and electroencephalography findings are compatible with infantile spasms
Spasms are intractable to the initial combination of vigabatrin (150 mg/kg) and topiramate (10 mg/kg) and/or additional indicated anti-epileptic drugs including prednisolone (2 mg/kg for 2 weeks and an additional 2 weeks for tapering).
Study entry requires magnetic resonance imaging to confirm the absence of a progressive cerebral lesion.

Exclusion Criteria:

Patients who have a history of hyperlipidaemia and underlying metabolic diseases including acute intermittent porphyria, pyruvate carboxylase deficiency, and fatty acid oxidation defects.
Patients who have a history of nephrolithiasis.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

5 Years

Standard Ages

Child

Study Population

refractory infantile spasms

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D013036	Spasms, Infantile

Ancestor Terms

ID	Term
D004829	Epilepsy, Generalized
D004827	Epilepsy
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
a short-term trial of the ketogenic diet
long-term trial of the ketogenic diet.