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

Refractory Epilepsy Clinical Trial

Official title:

Phase 2/3 Study of the Modified Atkins Diet in Young Children With Refractory Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01880333
• Other study ID #: MADRE
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 2012
• Est. completion date: March 2014

Study information

• Verified date: January 2019
• Source: Lady Hardinge Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Months to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Refractory Epilepsy

Intervention

Other:
• Modified Atkin Diet
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.

Locations

Country	Name	City	State
India	Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Lady Hardinge Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of children with seizure freedom at 3 months		3 months
Other	Percentage of children discontinuing diet before 3 months as per parenteral reports		3 months
Primary	Proportion of children with > 50% seizure reduction at 3 months		After 3 months of diet initiation
Secondary	Frequency of adverse effects of the modified Atkins diet.		3 months