Evaluation of the Modified Atkins Diet in Young Children With Refractory Epilepsy

Study Overview
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Brief Summary
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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.

Official Title
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Phase 2/3 Study of the Modified Atkins Diet in Young Children With Refractory Epilepsy

Conditions
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Refractory Epilepsy

Intervention / Treatment
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* Other: Modified Atkin Diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Children on Modified Atkin Diet<br> | Other: Modified Atkin Diet<br>* Eligible children will be started on Modified Atkins diet with help of trained dietician. Carbohydrates intake will be restricted to 5 grams/ day in children<18 mo and 10grams/day in children 18mo- 3 years.Carbohydrate values of various food items will be explained in detail. Fats (e.g. cream, butter, oils, and ghee) will be encouraged. Proteins (cheese, fish, eggs, chicken, and soya products) will be unrestricted. Calcium and multivitamin supplementation will be done. Syrups will be restricted. Clear carbohydrates free fluids- will not be restricted. Medications will be changed to carbohydrate free preparations, wherever available. Diary of events will be recorded including seizure frequency and any adverse or positive effect. Urine ketones chart will be maintained.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of children with > 50% seizure reduction at 3 months |  | After 3 months of diet initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of adverse effects of the modified Atkins diet. |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary therapy, Refractory epilepsy, non-pharmacological therapy, Modified Atkin Diet