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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00968136
Recruitment Status : Completed
First Posted : August 28, 2009
Last Update Posted : August 28, 2009
Information provided by:
Yonsei University

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

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Study Type : Observational
Observational Model: Cohort
Time Perspective: Prospective

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

Primary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

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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

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.

Layout table for additonal information 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:
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Spasms, Infantile
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases
Epileptic Syndromes