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

Phase 2

Completed

• Conditions: Refractory Epilepsy
• Interventions: Other: Simplified Modified Atkins Diet; Drug: Antiepileptic drugs alone

• Registration Number: NCT01899898
• Lead Sponsor: Lady Hardinge Medical College

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-06-14
• Study First Submitted QC: 2013-07-11
• Study First Posted: 2013-07-16
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-12
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simplified Modified Atkins Diet	Simplified Modified Atkins Diet	-
Antiepileptic drugs alone	Antiepileptic drugs alone	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Tolerability and the adverse effects of the simplified modified Atkins diet	3 months	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.

Trial Locations

Locations (1)

Division of Pediatric Neurology, Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital; 🇮🇳 New Delhi, Delhi, India