Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study
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ClinicalTrials.gov Identifier: NCT00968136 |
Recruitment Status
:
Completed
First Posted
: August 28, 2009
Last Update Posted
: August 28, 2009
|
Sponsor:
Yonsei University
Information provided by:
Yonsei University
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Brief Summary:
This is a randomized, controlled study to compare Short-term ketogenic diet with conventional long-term trial in refractory infantile spasms.
Condition or disease |
---|
Infantile Spasms |
Study Type : | Observational |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Resource links provided by the National Library of Medicine

Genetics Home Reference related topics:
CDKL5 deficiency disorder
Early infantile epileptic encephalopathy 1
MedlinePlus related topics:
Muscle Cramps
U.S. FDA Resources
Group/Cohort |
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a short-term trial of the ketogenic diet |
long-term trial of the ketogenic diet. |
Primary Outcome Measures
:
- Primary outcome measures include seizure relapse and frequency after successful completion of the ketogenic diet. [ Time Frame: 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. ]
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Ages Eligible for Study: | 1 Month to 5 Years (Child) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
Study Population
refractory infantile spasms
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.
No Contacts or Locations Provided
ClinicalTrials.gov Identifier: | NCT00968136 History of Changes |
Other Study ID Numbers: |
4-2006-0020 |
First Posted: | August 28, 2009 Key Record Dates |
Last Update Posted: | August 28, 2009 |
Last Verified: | August 2009 |
Keywords provided by Yonsei University:
refractory infantile spasms |
Additional relevant MeSH terms:
Spasm Spasms, Infantile Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Epilepsy, Generalized Epilepsy Brain Diseases Central Nervous System Diseases |