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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Satinder Aneja, Lady Hardinge Medical College
ClinicalTrials.gov Identifier:
NCT01549288
First received: March 6, 2012
Last updated: April 7, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Infantile Spasms
Behavioral: modified Atkins diet
Other: no dietetic input
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Modified Atkins Diet in Children With Infantile Spasms Refractory to Hormonal Therapy: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Lady Hardinge Medical College:

Primary Outcome Measures:
  • Proportion of children who achieved spasm freedom as per parental reports at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of children who achieved >50% reduction of clinical spasm, as per parental reports at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: modified Atkins diet Behavioral: modified Atkins diet
Carbohydrate restricted to 10 g/day (18-36 months) and 5 g/day (9-18 months), fat intake encouraged, proteins unrestricted
control arm
the control arm continues the anti-epileptic drugs without any added dietetic input
Other: no dietetic input
continuation of anti-epileptic medication without any dietetic input

  Eligibility

Ages Eligible for Study:   9 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01549288

Locations
India
Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital
New Delhi, Delhi, India, 110001
Sponsors and Collaborators
Lady Hardinge Medical College
  More Information

No publications provided

Responsible Party: Satinder Aneja, Assistant Professor, Lady Hardinge Medical College
ClinicalTrials.gov Identifier: NCT01549288     History of Changes
Other Study ID Numbers: RADIS
Study First Received: March 6, 2012
Last Updated: April 7, 2013
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Spasm
Spasms, Infantile
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014