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Completed

NCT Number: NCT01880333

Evaluation of the Modified Atkins Diet in Young Children With Refractory Epilepsy

The modified Atkins diet is a non-pharmacologic therapy for intractable childhood epilepsy that was designed to be a less restrictive alternative to the traditional ketogenic diet. This diet is started on an outpatient basis without a fast, allows unlimited protein and fat, and does not restrict calories or fluids. Modified Atkins diet is of special importance in resource constraint settings with paucity of trained dieticians. However, there is paucity published data on the use of the modified Atkins diet in refractory epilepsy in young children. This study aims to evaluate the efficacy and tolerability of the modified Atkins diet in refractory epilepsy in young children.

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Key information

Conditions

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

Age range

9 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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: 9 months to 3 years.
  • Seizures persisting at least three per week for > 1 month despite the appropriate use of at least 2 Anti-epileptic drugs.

Exclusion criteria

  • Known or suspected inborn error of metabolism, as evidenced by: 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 And/ or 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.
  • Motivational or psychosocial issues in the family which would preclude compliance
  • Systemic illness- chronic hepatic, cardiac, renal or pulmonary disease
  • Severe acute malnutrition.

Treatment and study plan

Modified Atkin Diet

Other

Eligible children will be started on Modified Atkins diet with help of trained dietician. Carbohydrates intake will be restricted to 5 grams/ day in children<18 mo and 10grams/day in children 18mo- 3 years.Carbohydrate values of various food items will be explained in detail. Fats (e.g. cream, butter, oils, and ghee) will be encouraged. Proteins (cheese, fish, eggs, chicken, and soya products) will be unrestricted. Calcium and multivitamin supplementation will be done. Syrups will be restricted. Clear carbohydrates free fluids- will not be restricted. Medications will be changed to carbohydrate free preparations, wherever available. Diary of events will be recorded including seizure frequency and any adverse or positive effect. Urine ketones chart will be maintained.

Primary outcomes

  1. Proportion of children with > 50% seizure reduction at 3 months

    Time frame: After 3 months of diet initiation

Secondary outcomes

  1. Frequency of adverse effects of the modified Atkins diet.

    Time frame: 3 months

Other outcomes

  1. Proportion of children with seizure freedom at 3 months

    Time frame: 3 months

  2. Percentage of children discontinuing diet before 3 months as per parenteral reports

    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 the Modified Atkins Diet in Young Children With Refractory Epilepsy

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 18, 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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