Status:
COMPLETED
Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study
Lead Sponsor:
Yonsei University
Conditions:
Infantile Spasms
Eligibility:
All Genders
1-5 years
Brief Summary
This is a randomized, controlled study to compare Short-term ketogenic diet with conventional long-term trial in refractory infantile spasms.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
OBSERVATIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00968136
Last Update
August 28 2009
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