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
  Purpose

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


Condition
Infantile Spasms

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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome 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. ]

Groups/Cohorts
a short-term trial of the ketogenic diet
long-term trial of the ketogenic diet.

  Eligibility

Ages Eligible for Study:   1 Month to 5 Years
Genders Eligible for Study:   Both
Sampling Method:   Non-Probability Sample
Study Population

refractory infantile spasms

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.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00968136     History of Changes
Other Study ID Numbers: 4-2006-0020
Study First Received: August 27, 2009
Last Updated: August 27, 2009
Health Authority: Korea: Food and Drug Administration
Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Yonsei University:
refractory infantile spasms

Additional relevant MeSH terms:
Spasm
Spasms, Infantile
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on August 20, 2014