Status:
COMPLETED
Evaluation of the Modified Atkins Diet in Young Children With Refractory Epilepsy
Lead Sponsor:
Lady Hardinge Medical College
Conditions:
Refractory Epilepsy
Eligibility:
All Genders
9-3 years
Phase:
PHASE2
PHASE3
Brief Summary
The modified Atkins diet is a non-pharmacologic therapy for intractable childhood epilepsy that was designed to be a less restrictive alternative to the traditional ketogenic diet. This diet is starte...
Eligibility Criteria
Inclusion
- Age: 9 months to 3 years.
- Seizures persisting at least three per week for \> 1 month despite the appropriate use of at least 2 Anti-epileptic drugs.
Exclusion
- Known or suspected inborn error of metabolism, as evidenced by: 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 And/ or 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.
- Motivational or psychosocial issues in the family which would preclude compliance
- Systemic illness- chronic hepatic, cardiac, renal or pulmonary disease
- Severe acute malnutrition.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01880333
Start Date
November 1 2012
End Date
March 1 2014
Last Update
January 15 2019
Active Locations (1)
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1
Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital
New Delhi, National Capital Territory of Delhi, India, 110001