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OpenTrials
Completed

NCT Number: NCT01899898

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

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.

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Key information

Conditions

Refractory Epilepsy Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Epilepsy Nervous System Diseases

Age range

2 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simplified Modified Atkins Diet

Other

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.

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

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

    Time frame: 3 months

Secondary outcomes

  1. Tolerability and the adverse effects of the simplified modified Atkins diet

    Time frame: 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.

Other outcomes

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

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Lady Hardinge Medical College

Other Gov

Registry information

Official study title

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

Acronym: SMAD

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 16, 2013
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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