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

Infantile Spasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01549288
• Other study ID #: RADIS
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: March 6, 2012
• Last updated: April 7, 2013
• Start date: February 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2013
• Source: Lady Hardinge Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Months to 36 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infantile Spasms
• Spasm
• Spasms, Infantile

Intervention

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

Other:
• no dietetic input
continuation of anti-epileptic medication without any dietetic input

Locations

Country	Name	City	State
India	Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Lady Hardinge Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of children who achieved spasm freedom as per parental reports at 4 weeks		4 weeks	No
Secondary	Proportion of children who achieved >50% reduction of clinical spasm, as per parental reports at 4 weeks		4 weeks	No