Trial of the Modified Atkins Diet in Infantile Spasms Refractory to Hormonal Therapy

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Brief Title

Trial of the Modified Atkins Diet in Infantile Spasms Refractory to Hormonal Therapy

Official Title

Evaluation of the Modified Atkins Diet in Children With Infantile Spasms Refractory to Hormonal Therapy: a Randomized Controlled Trial

Brief Summary

      Infantile spasms comprise an infantile epileptic encephalopathy characterized by
      hypsarrhythmia on EEG, and frequent neurodevelopmental regression. Unfortunately the
      treatment of this disorder remains difficult. The first-line options which include hormonal
      therapy, i.e., adrenocorticotropic hormone (ACTH) or oral corticosteroids, and vigabatrin are
      effective in 60-70% of the patients. Hormonal therapy is considered the best available
      treatment. Vigabatrin being expensive and of limited availability is not a feasible option
      for most patients in our setting. Also, these are however associated with significant side
      effects, and high relapse rates. Newer drugs such as topiramate, zonisamide, and
      levetiracetam have also been evaluated; however these drugs are less effective than ACTH. The
      ketogenic diet (KD) is a high fat, low carbohydrate diet. It has been used for treatment of
      intractable childhood epilepsy. The KD has also been shown to be effective for intractable
      infantile spasms; often after ACTH and vigabatrin have failed.

      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. Preliminary data have shown efficacy in refractory
      infantile spasms. This diet is also ideal for resource-constraint settings with paucity of
      trained dieticians. Hence this study has been planned to evaluate the efficacy and
      tolerability of the modified Atkins diet in children with infantile spasms refractory to
      hormonal treatment in a randomized controlled trial.
    


Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Proportion of children who achieved spasm freedom as per parental reports at 4 weeks

Secondary Outcome

 Proportion of children who achieved >50% reduction of clinical spasm, as per parental reports at 4 weeks

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

Behavioral

Estimated Enrollment

0

Start Date

February 2012

Completion Date

December 2013

Primary Completion Date

October 2013

Eligibility Criteria

        Inclusion Criteria:

          1. age 9 months to 3 years

          2. Presence of epileptic spasms in clusters in child 9 months to < 3years of age, with
             electroencephalographic evidence of hypsarrhythmia or its variants), persisting, at
             least one cluster per day, despite treatment with either oral corticosteroids or
             adrenocorticotrophic hormone (ACTH) and one additional anticonvulsant
             (valproate/benzodiazepine/vigabatrin/topiramate/zonisamide/ levetiracetam) for at
             least 4 weeks.

        Exclusion Criteria:

          -  Children with known or suspected inborn error of metabolism, Patients with 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

          -  With or without 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. In such patients, blood
                  tandem mass spectrometry or urine gas chromatography mass spectroscopy (GCMS)
                  will be obtained to look for inborn error of metabolism.

          -  Children with renal, pulmonary, cardiac or hepatic dysfunction

          -  Severe malnutrition (weight for length and height for age less than 3 SD for mean as
             per WHO growth charts),

          -  Children from families who lack motivation will also be excluded as it might affect
             the compliance.
      

Gender

All

Ages

9 Months - 36 Months

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

India

Location Countries

India

Administrative Informations


NCT ID

NCT01549288

Organization ID

RADIS


Responsible Party

Principal Investigator

Study Sponsor

Lady Hardinge Medical College


Study Sponsor

, , 


Verification Date

April 2013