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

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

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.

Trial design

0 participants in 2 patient groups

a short-term trial of the ketogenic diet

long-term trial of the ketogenic diet.