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

NCT00968136 | Completed

• 1 other identifier: 4-2006-0020
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Infantile Spasms

Keywords

refractory infantile spasms

Outcome Measures

Primary Outcomes (1)

• Primary outcome measures include seizure relapse and frequency after successful completion of the ketogenic diet.

  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.

Study Arms (2)

a short-term trial of the ketogenic diet

long-term trial of the ketogenic diet.

Eligibility Criteria

• Age: 1 Month - 5 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

refractory infantile spasms

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

MeSH Terms

Conditions

Spasms, Infantile

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: August 28, 2009
• Last Updated: August 28, 2009

Record last verified: 2009-08