Use of the Modified Atkins Diet in Infantile Spasms

Study Overview
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Brief Summary
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Infantile spasms constitute a type of catastrophic epilepsy syndrome occuring in young children. The ketogenic diet has been shown to be very effective in these children. The modified Atkins diet is a less restrictive option than the ketogenic diet, which has been effective in preliminary studies on refractory epilepsy in children, adolescents and adults. Modified Atkins diet may be of special importance in infants, as proteins are not restricted, hence no problems with growth are expected. Hence this pilot study has been planned to evaluate the efficacy and tolerability of the modified Atkins diet in infantile spasms refractory to conventional treatment (ACTH, vigabatrin, and anti-epileptic drugs).

Official Title
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Efficacy and Tolerability of the Modified Atkins Diet in Patients With Infantile Spasms: a Pilot Study.

Conditions
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Infantile Spasms

Intervention / Treatment
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* Dietary Supplement: modified Atkins diet
* Other: modified Atkins diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 6 months to 3 years. Presence of epileptic spasms in clusters, with electroencephalographic evidence of hypsarrhythmia or its variants), having at least one cluster per day. Treatment with at least corticosteroid/ ACTH or Vigabatrin and one other AED( sodium valproate, pyridoxine, topiramate, zonisamide, benzodiazepines (clobazam, clonazepam, nitrazepam). 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

Ages Eligible for Study
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Minimum Age: 6 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: modified Atkins diet<br> | Dietary Supplement: modified Atkins diet<br>* Modified Atkins Diet administration Carbohydrates intake restricted to 10 grams/ day. (Carbohydrate values of various food items will be explained in detail, and exchange lists provided. Four 2.5 grams carbohydrate exchange items will be allowed in a day.) Fats (e.g. cream, butter, oils, ghee) encouraged. Proteins (cheese, fish, eggs, chicken, soya products) unrestricted. Clear carbohydrate-fluids not restricted. Calcium and multivitamin supplementation will be provided.<br>* Other names: Dietary treatment;Other: modified Atkins diet<br>* Modified Atkins Diet administration Carbohydrates intake restricted to 10 grams/ day. (Carbohydrate values of various food items will be explained in detail, and exchange lists provided. Four 2.5 grams carbohydrate exchange items will be allowed in a day.) Fats (e.g. cream, butter, oils, ghee) encouraged. Proteins (cheese, fish, eggs, chicken, soya products) unrestricted. Clear carbohydrate-fluids not restricted. Calcium and multivitamin supplementation will be provided.<br>* Other names: Dietary treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seizure reduction as per parental reports | seizure control at the end of 3 months will be classified as: spasm free; > 50% reduction in spasms; and < 50% reduction in spasms | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse effects of the diet as per parental reports |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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West syndrome, Hypsarrhythmia