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

NCT01880333 | Completed Phase 2 DMC

• 1 other identifier: MADRE
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Epilepsy

Keywords

Refractory epilepsy; dietary therapy; non-pharmacological therapy; Modified Atkin Diet

Outcome Measures

Primary Outcomes (1)

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

  After 3 months of diet initiation

Secondary Outcomes (1)

• Frequency of adverse effects of the modified Atkins diet.

  3 months

Other Outcomes (2)

• Proportion of children with seizure freedom at 3 months

  3 months

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

  3 months

Study Arms (1)

Children on Modified Atkin Diet

EXPERIMENTAL

Other: Modified Atkin Diet

Interventions

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.

Children on Modified Atkin Diet

Eligibility Criteria

• Age: 9 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lady Hardinge Medical College: lead

Study Sites (1)

Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital

New Delhi, National Capital Territory of Delhi, 110001, India

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Satinder Aneja, MD

  Kalawati Saran Children's Hospital, Lady Hardinge Medical College, New Delhi, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Professor

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 18, 2013
• Study Start: November 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: January 15, 2019

Record last verified: 2019-01

Locations

IN (1)