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

NCT ID: NCT01549288

Last Updated: 2013-04-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-12-31

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.

Conditions

Infantile Spasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

modified Atkins diet

Group Type: EXPERIMENTAL

modified Atkins diet

Intervention Type: BEHAVIORAL

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

Group Type: OTHER

no dietetic input

Intervention Type: OTHER

continuation of anti-epileptic medication without any dietetic input

Interventions

modified Atkins diet

Carbohydrate restricted to 10 g/day (18-36 months) and 5 g/day (9-18 months), fat intake encouraged, proteins unrestricted

Intervention Type: BEHAVIORAL

no dietetic input

continuation of anti-epileptic medication without any dietetic input

Intervention Type: OTHER

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.

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lady Hardinge Medical College

OTHER_GOV

Sponsor Role: lead

Responsible Party

Satinder Aneja

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

RADIS

Identifier Type: -

Identifier Source: org_study_id