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

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Brief Title

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


Brief Summary

      This is a randomized, controlled study to compare Short-term ketogenic diet with conventional
      long-term trial in refractory infantile spasms.
    



Study Type

Observational


Primary Outcome

Primary outcome measures include seizure relapse and frequency after successful completion of the ketogenic diet.


Condition

Infantile Spasms


Study Arms / Comparison Groups

 a short-term trial of the ketogenic diet
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information







Eligibility Criteria

        Inclusion Criteria:

          1. Patients, who have recalcitrant infantile spasms and undertake the ketogenic diet at
             Severance Hospital and Sanggye Paik Hospital from 2005 to 2008.

          2. Clinical and electroencephalography findings are compatible with infantile spasms

          3. 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).

          4. Study entry requires magnetic resonance imaging to confirm the absence of a
             progressive cerebral lesion.

        Exclusion Criteria:

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

          2. Patients who have a history of nephrolithiasis.
      

Gender

All

Ages

1 Month - 5 Years


Contacts

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Administrative Informations


NCT ID

NCT00968136

Organization ID

4-2006-0020



Study Sponsor

Yonsei University


Study Sponsor

, , 


Verification Date

August 2009