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

Lady Hardinge Medical College

Status and phase: Completed; Phase 3; Phase 2

Conditions: Refractory Epilepsy

Treatments: Other: Modified Atkin Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT01880333

MADRE

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 9 months to 3 years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Children on Modified Atkin Diet

Experimental group

Treatment:

Other: Modified Atkin Diet