Phase 2/3 Study of the Modified Atkins Diet in Young Children With Refractory Epilepsy
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Refractory Epilepsy
- Sponsor
- Lady Hardinge Medical College
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Proportion of children with > 50% seizure reduction at 3 months
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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 started on an outpatient basis without a fast, allows unlimited protein and fat, and does not restrict calories or fluids. Modified Atkins diet is of special importance in resource constraint settings with paucity of trained dieticians. However, there is paucity published data on the use of the modified Atkins diet in refractory epilepsy in young children. This study aims to evaluate the efficacy and tolerability of the modified Atkins diet in refractory epilepsy in young children.
Investigators
Satinder Aneja
Director Professor
Lady Hardinge Medical College
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Proportion of children with > 50% seizure reduction at 3 months
Time Frame: After 3 months of diet initiation
Secondary Outcomes
- Frequency of adverse effects of the modified Atkins diet.(3 months)