Refractory Epilepsy
Conditions
Keywords
Refractory epilepsy, dietary therapy, non-pharmacological therapy, Modified Atkin Diet
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.
Interventions
OTHERModified Atkin Diet
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.
Sponsors
Lady Hardinge Medical College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Months to 3 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 9 months to 3 years. 2. Seizures persisting at least three per week for \> 1 month despite the appropriate use of at least 2 Anti-epileptic drugs.
Exclusion criteria
1. 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. 2. Motivational or psychosocial issues in the family which would preclude compliance 3. Systemic illness- chronic hepatic, cardiac, renal or pulmonary disease 4. Severe acute malnutrition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of children with > 50% seizure reduction at 3 months | After 3 months of diet initiation |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of adverse effects of the modified Atkins diet. | 3 months |
Other
| Measure | Time frame |
|---|---|
| Proportion of children with seizure freedom at 3 months | 3 months |
| Percentage of children discontinuing diet before 3 months as per parenteral reports | 3 months |
Countries
India
Outcome results
None listed