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

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00968136
First received: August 27, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted

August 27, 2009
August 27, 2009
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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. ]
Same as current
No Changes Posted
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Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study
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This is a randomized, controlled study to compare Short-term ketogenic diet with conventional long-term trial in refractory infantile spasms.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

refractory infantile spasms

Infantile Spasms
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  • a short-term trial of the ketogenic diet
  • long-term trial of the ketogenic diet.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
1 Month to 5 Years
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Contact information is only displayed when the study is recruiting subjects
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NCT00968136
4-2006-0020
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Yonsei University
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Yonsei University
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP