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

Primary Purpose

Refractory Epilepsy

Status

Completed

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Simplified Modified Atkins Diet

Antiepileptic drugs alone

About this trial

This is an interventional treatment trial for Refractory Epilepsy focused on measuring Refractory epilepsy, Dietary therapy, Non-Pharmacological therapy, Simplified Modified Atkins Diet

Eligibility Criteria

2 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Simplified Modified Atkins Diet

Antiepileptic drugs alone

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01899898

First Posted

June 14, 2013

Last Updated

January 12, 2019

Sponsor

Lady Hardinge Medical College

1. Study Identification

Unique Protocol Identification Number

NCT01899898

Brief Title

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

Acronym

SMAD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lady Hardinge Medical College

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractory Epilepsy

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Simplified Modified Atkins Diet

Arm Type

Experimental

Arm Title

Antiepileptic drugs alone

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Simplified Modified Atkins Diet

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Antiepileptic drugs alone

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Tolerability and the adverse effects of the simplified modified Atkins diet

Description

Time Frame

3 months

Other Pre-specified Outcome Measures:

Title

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Satinder Aneja, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110001

Country

India

12. IPD Sharing Statement

Citations:

PubMed Identifier

32588435

Citation

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.

Results Reference

derived

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

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