Clinical trial NCT01880333: Evaluation of the Modified Atkins Diet in Young Children With Refractory Epilepsy
Official title: Phase 2/3 Study of the Modified Atkins Diet in Young Children With Refractory Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Refractory Epilepsy
Keywords: Refractory epilepsy
dietary therapy
non-pharmacological therapy
Modified Atkin Diet
Lead sponsor: Lady Hardinge Medical College
Sponsor class: OTHER_GOV
First posted: 2013-06-18
Enrollment: 31
Sex: ALL
Minimum age (years): 9
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of children with > 50% seizure reduction at 3 months
timeFrame: After 3 months of diet initiation
Secondary outcomes:
measure: Frequency of adverse effects of the modified Atkins diet.
timeFrame: 3 months
Other outcomes:
measure: Proportion of children with seizure freedom at 3 months
timeFrame: 3 months
measure: Percentage of children discontinuing diet before 3 months as per parenteral reports
timeFrame: 3 months
Locations:
city: New Delhi
country: India
facility: Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital
state: Delhi
Study officials:
affiliation: Kalawati Saran Children's Hospital, Lady Hardinge Medical College, New Delhi, India
name: Satinder Aneja, MD
role: PRINCIPAL_INVESTIGATOR
References: