Use of the Modified Atkins Diet in Infantile Spasms

Overview

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).

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2010

Interventions

  • Dietary Supplement: modified Atkins diet
    • 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.
  • Other: modified Atkins diet
    • 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.

Arms, Groups and Cohorts

  • Experimental: modified Atkins diet

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • adverse effects of the diet as per parental reports
    • Time Frame: 3 months

Participating in This Clinical Trial

Inclusion Criteria

1. Age: 6 months to 3 years. 2. Presence of epileptic spasms in clusters, with electroencephalographic evidence of hypsarrhythmia or its variants), having at least one cluster per day. 3. Treatment with at least corticosteroid/ ACTH or Vigabatrin and one other AED( sodium valproate, pyridoxine, topiramate, zonisamide, benzodiazepines (clobazam, clonazepam, nitrazepam). 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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 3 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • All India Institute of Medical Sciences, New Delhi
  • Provider of Information About this Clinical Study
    • Dr Suvasini Sharma, All India Institute of Medical Sciences
  • Overall Official(s)
    • Suvasini Sharma, MD, DM, Principal Investigator, All India Institute of Medical Sciences, New Delhi
    • Sheffali Gulati, MD, Study Director, All India Institute of Medical Sciences, New Delhi

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