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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01549288
Recruitment Status : Withdrawn
First Posted : March 9, 2012
Last Update Posted : April 9, 2013
Information provided by (Responsible Party):
Satinder Aneja, Lady Hardinge Medical College

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : December 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Proportion of children who achieved spasm freedom as per parental reports at 4 weeks [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Proportion of children who achieved >50% reduction of clinical spasm, as per parental reports at 4 weeks [ Time Frame: 4 weeks ]

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Ages Eligible for Study:   9 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01549288

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

Responsible Party: Satinder Aneja, Assistant Professor, Lady Hardinge Medical College Identifier: NCT01549288     History of Changes
Other Study ID Numbers: RADIS
First Posted: March 9, 2012    Key Record Dates
Last Update Posted: April 9, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Spasms, Infantile
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases