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

Phase 2

Completed

• Conditions: Refractory Epilepsy
• Interventions: Other: Modified Atkin Diet

• Registration Number: NCT01880333
• Lead Sponsor: Lady Hardinge Medical College

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-06-13
• Study First Submitted QC: 2013-06-14
• Study First Posted: 2013-06-18
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-12
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

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

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Exclusion Criteria

1. 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.
2. Motivational or psychosocial issues in the family which would preclude compliance
3. Systemic illness- chronic hepatic, cardiac, renal or pulmonary disease
4. Severe acute malnutrition.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children on Modified Atkin Diet	Modified Atkin Diet	-

Primary Outcome Measures

Name	Time	Method
Proportion of children with > 50% seizure reduction at 3 months	After 3 months of diet initiation

Secondary Outcome Measures

Name	Time	Method
Frequency of adverse effects of the modified Atkins diet.	3 months

Trial Locations

Locations (1)

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