Use of the Modified Atkins Diet in Infantile Spasms

Learn more about:
Related Clinical Trial
The Effect of Spa and Massage on Babies on Colic Symptoms Ketogenic Diet vs ACTH for the Treatment of Children With West Syndrome Multicentre Real-life Follow-up Study of Rare Epileptic Syndromes in Children and Adolescents Tricaprilin Infantile Spasms Pilot Study Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm Sabril Patient Registry Epilepsy Phenome/Genome Project Metabolic Abnormalities in Children With Epilepsy Genetics of Severe Early Onset Epilepsies A Novel Approach to Infantile Spasms Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile Spasms Prednisolone in Infantile Spasms- High Dose Versus Usual Dose Addition of Pyridoxine to Prednisolone in Infantile Spasms Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy Trial of the Modified Atkins Diet in Infantile Spasms Refractory to Hormonal Therapy An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7) A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7) Open-label Extension to Protocol 1042-0500 Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms Prevention of West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH) Evaluation of Neuroinflammation in Children With Infantile Spasms Molecular Genetics in Infantile Spasms Genetic Studies in Patients and Families With Infantile Spasms Use of the Modified Atkins Diet in Infantile Spasms Treatment of Refractory Infantile Spasms With Fenfluramine A Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms

Brief Title

Use of the Modified Atkins Diet in Infantile Spasms

Official Title

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

Brief Summary

      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).

Study Phase

Phase 2/Phase 3

Study Type


Primary Outcome

seizure reduction as per parental reports

Secondary Outcome

 adverse effects of the diet as per parental reports


Infantile Spasms


modified Atkins diet

Study Arms / Comparison Groups

 modified Atkins diet


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Dietary Supplement

Estimated Enrollment


Start Date

October 2009

Completion Date

November 2010

Primary Completion Date

October 2010

Eligibility Criteria

        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,

        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




6 Months - 3 Years

Accepts Healthy Volunteers



Suvasini Sharma, MD, DM, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Study Sponsor

All India Institute of Medical Sciences, New Delhi

Study Sponsor

Suvasini Sharma, MD, DM, Principal Investigator, All India Institute of Medical Sciences, New Delhi

Verification Date

November 2010