Status:
COMPLETED
Efficacy of a Simplified Modified Atkins Diet in Children With Refractory Epilepsy
Lead Sponsor:
Lady Hardinge Medical College
Conditions:
Refractory Epilepsy
Eligibility:
All Genders
2-14 years
Phase:
PHASE2
PHASE3
Brief Summary
One third of children with epilepsy have seizures that are medically intractable. Uncontrolled seizures pose a variety of risks to children, including higher rates of mortality, developmental delay an...
Eligibility Criteria
Inclusion
- Age: 2 - 14 years.
- Seizures persisting daily or more than 7 per week despite the use of at least 2 anti-epileptic drugs in appropriate doses and levels (whenever available) in suitable to the syndrome and EEG findings.
Exclusion
- Known or suspected inborn error of metabolism:
- Patients with clinical suspicion of metabolic disorder as evidenced by 2 or more of the following- a history of parental consanguinity, prior affected siblings, unexplained vomiting, intermittent worsening of symptoms, recurrent episodes of lethargy, altered sensorium, or ataxia, hepatosplenomegaly on examination With or without 2 or more of the following biochemical abnormalities High blood ammonia (\>80mmol/L), High arterial lactate (\>2 mmol/L), metabolic acidosis (pH \<7.2), hypoglycaemia (blood sugar \<40 mg/dl), abnormal urinary aminoacidogram, presence of reducing sugars or ketones in urine, and positive results on urine neurometabolic screening tests.
- In such patients, blood tandem mass spectrometry or urine gas chromatography mass spectroscopy (GCMS) will be obtained to look for inborn error of metabolism.
- Surgically remediable causes of epilepsy such as tumors, cortical dysplasias, mesial temporal lobe epilepsy etc with refractory focal epilepsy.
- We will perform MRI brain, and short term video-EEG in all patients with focal seizures to look for surgically remediable causes.
- Motivational or psychosocial issues in the family which would preclude compliance
- Systemic illness- chronic hepatic, renal or pulmonary disease
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT01899898
Start Date
September 1 2012
End Date
November 1 2015
Last Update
January 15 2019
Active Locations (1)
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1
Division of Pediatric Neurology, Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital
New Delhi, National Capital Territory of Delhi, India, 110001