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

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Yonsei University

Status

Completed

Conditions

Infantile Spasms

Study type

Observational

Funder types

Other

Identifiers

NCT00968136
4-2006-0020

Details and patient eligibility

About

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

Sex

All

Ages

1 month to 5 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients, who have recalcitrant infantile spasms and undertake the ketogenic diet at Severance Hospital and Sanggye Paik Hospital from 2005 to 2008.
  • Clinical and electroencephalography findings are compatible with infantile spasms
  • 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).
  • Study entry requires magnetic resonance imaging to confirm the absence of a progressive cerebral lesion.

Exclusion criteria

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

Trial design

0 participants in 2 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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