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

NCT ID: NCT01899898

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-11-30

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

Study Design

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

Study Groups

Simplified Modified Atkins Diet

Group Type: EXPERIMENTAL

Simplified Modified Atkins Diet

Intervention Type: 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.

Antiepileptic drugs alone

Group Type: ACTIVE_COMPARATOR

Antiepileptic drugs alone

Intervention Type: DRUG

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

Interventions

Simplified Modified Atkins Diet

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.

Intervention Type: OTHER

Antiepileptic drugs alone

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lady Hardinge Medical College

OTHER_GOV

Sponsor Role: lead

Responsible Party

Satinder Aneja

Director Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Satinder Aneja, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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, India

Countries

India

References

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.

Reference Type: DERIVED

PMID: 32588435 (View on PubMed)

Other Identifiers

SMAD

Identifier Type: -

Identifier Source: org_study_id