Efficacy of a Simplified Modified Atkins Diet in Children With Refractory Epilepsy

NCT01899898 | Completed Phase 2 DMC

• 1 other identifier: SMAD
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

One third of children with epilepsy have seizures that are medically intractable. Uncontrolled seizures pose a variety of risks to children, including higher rates of mortality, developmental delay and cognitive impairment. Epilepsy surgery is not a feasible option for most children with refractory epilepsy. The ketogenic diet and the modified Atkins diet have been shown to be effective alternative treatments in children with refractory epilepsy. However, these need parents to be educated, and understand complex instructions of weighing foods and diet preparation. Therefore, children with parents with low levels of literacy and poor socioeconomic status have not been able to benefit from these therapies. Also, the paucity of trained dieticians and limited availability of labeled foods in resource-constraint settings has made these dietary therapies even more inaccessible. This study aimed to to develop a simple-to-administer variation of the modified Atkins diet for use in children with refractory epilepsy and to evaluate the efficacy and tolerability of this simplified modified Atkins diet in children with refractory epilepsy in a randomized controlled open-label trial.

Conditions

Refractory Epilepsy

Keywords

Refractory epilepsy; Dietary therapy; Non-Pharmacological therapy; Simplified Modified Atkins Diet

Outcome Measures

Primary Outcomes (1)

• The proportion patients who achieve > 50% seizure reduction from the baseline in the simplified modified Atkins diet plus anti-epileptic drug therapy group at 3 months in comparison to the anti-epileptic drug therapy alone group

  3 months

Secondary Outcomes (1)

• Tolerability and the adverse effects of the simplified modified Atkins diet

  3 months

Other Outcomes (1)

• Proportion of patients withdrawing from the simplified modified Atkins diet plus antiepileptic drug treatment group during the study period

  3 months

Study Arms (2)

Simplified Modified Atkins Diet

EXPERIMENTAL

Other: Simplified Modified Atkins Diet

Antiepileptic drugs alone

ACTIVE COMPARATOR

Drug: Antiepileptic drugs alone

Interventions

Simplified Modified Atkins Diet OTHER

Modified Atkins diet with the following modifications: 1. Pictorial representation of various food items and exchange lists will be provided. 2. Instead of weights, we will provide standardized measures 3. We will calculate the amount of carbohydrates of daily readily available foods in the standardized measures 4. We will formulate recipes and diets based on locally available and culturally acceptable foods. 5. We will develop a parent instruction manual. 6. We will also develop methods for parents with low levels of literacy to maintain seizure logs. This will be done by using bars and color codes. 7. We will develop methods for parents with low levels of literacy to measure and record urine ketones. This will be done by using color codes.

Simplified Modified Atkins Diet

Antiepileptic drugs alone DRUG

The anti-epileptic drugs will be continued alone for 3 months following which they will be offered Simplified Modified Atkins Diet

Antiepileptic drugs alone

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 2 - 14 years.
• Seizures persisting daily or more than 7 per week despite the use of at least 2 anti-epileptic drugs in appropriate doses and levels (whenever available) in suitable to the syndrome and EEG findings.

You may not qualify if:

• 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.
• Surgically remediable causes of epilepsy such as tumors, cortical dysplasias, mesial temporal lobe epilepsy etc with refractory focal epilepsy.
• We will perform MRI brain, and short term video-EEG in all patients with focal seizures to look for surgically remediable causes.
• Motivational or psychosocial issues in the family which would preclude compliance
• Systemic illness- chronic hepatic, renal or pulmonary disease

Sponsors & Collaborators

• Lady Hardinge Medical College: lead

Study Sites (1)

Division of Pediatric Neurology, Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital

New Delhi, National Capital Territory of Delhi, 110001, India

Location

Related Publications (1)

• Martin-McGill KJ, Bresnahan R, Levy RG, Cooper PN. Ketogenic diets for drug-resistant epilepsy. Cochrane Database Syst Rev. 2020 Jun 24;6(6):CD001903. doi: 10.1002/14651858.CD001903.pub5.

  PMID: 32588435 DERIVED

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Anticonvulsants

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Satinder Aneja, MD

  Pediatric Neurology, Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Professor

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: July 16, 2013
• Study Start: September 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 15, 2019

Record last verified: 2019-01

Locations

IN (1)