Use of the Modified Atkins Diet in Infantile Spasms

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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

Interventional


Primary Outcome

seizure reduction as per parental reports

Secondary Outcome

 adverse effects of the diet as per parental reports

Condition

Infantile Spasms

Intervention

modified Atkins diet

Study Arms / Comparison Groups

 modified Atkins diet
Description:  

Publications

* 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

15

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,
             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

All

Ages

6 Months - 3 Years

Accepts Healthy Volunteers

No

Contacts

Suvasini Sharma, MD, DM, , 

Location Countries

India

Location Countries

India

Administrative Informations


NCT ID

NCT01006811

Organization ID

ADIS



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