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:
Yonsei University
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
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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:
Genetics Home Reference related topics:
X-linked infantile spasm syndrome
pyridoxal 5'-phosphate-dependent epilepsy
MedlinePlus related topics:
Muscle Cramps
U.S. FDA Resources
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 (Child) |
| Genders Eligible for Study: | Both |
| Sampling Method: | Non-Probability Sample |
Study Population
refractory infantile spasms
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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More Information
| 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 and Welfare |
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 September 23, 2016