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

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective

Arms, Groups and Cohorts

  • a short-term trial of the ketogenic diet
  • long-term trial of the ketogenic diet.

Clinical Trial Outcome Measures

Primary 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.

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 1 Month

Maximum Age: 5 Years

Investigator Details

  • Lead Sponsor
    • Yonsei University

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