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

Refractory Epilepsy Clinical Trial

— SMAD  

Official title:

Phase 2/3 Study of a Simplified Modified Atkins Diet in Children With Refractory Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899898
• Other study ID #: SMAD
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 2012
• Est. completion date: November 2015

Study information

• Verified date: January 2019
• Source: Lady Hardinge Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 14 Years

Eligibility

Inclusion Criteria:

1. Age: 2 - 14 years.

2. 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.

Exclusion Criteria:

1. 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.

2. 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.

3. Motivational or psychosocial issues in the family which would preclude compliance

4. Systemic illness- chronic hepatic, renal or pulmonary disease

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Refractory Epilepsy

Intervention

Other:
• Simplified Modified Atkins Diet
Modified Atkins diet with the following modifications: Pictorial representation of various food items and exchange lists will be provided. Instead of weights, we will provide standardized measures We will calculate the amount of carbohydrates of daily readily available foods in the standardized measures We will formulate recipes and diets based on locally available and culturally acceptable foods. We will develop a parent instruction manual. 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. 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.

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

Locations

Country	Name	City	State
India	Division of Pediatric Neurology, Department of Pediatrics, 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
Other	Proportion of patients withdrawing from the simplified modified Atkins diet plus antiepileptic drug treatment group during the study period		3 months
Primary	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	Tolerability and the adverse effects of the simplified modified Atkins diet	Tolerability of the diet and any adverse events will be evaluated by means of parental interview at each visit. Parents will be questioned for the following symptoms - vomiting, lethargy, poor appetite, refusal to feed and constipation in particular. Any other parental concerns will also be noted. The proportion of patients with each symptom in both the groups will be evaluated.	3 months