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

Primary Purpose

Refractory Epilepsy

Status

Completed

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Modified Atkin Diet

About this trial

This is an interventional treatment trial for Refractory Epilepsy focused on measuring Refractory epilepsy, dietary therapy, non-pharmacological therapy, Modified Atkin Diet

Eligibility Criteria

9 Months - 3 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Children on Modified Atkin Diet

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Frequency of adverse effects of the modified Atkins diet.

Full Information

NCT ID

NCT01880333

First Posted

June 13, 2013

Last Updated

January 12, 2019

Sponsor

Lady Hardinge Medical College

1. Study Identification

Unique Protocol Identification Number

NCT01880333

Brief Title

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

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lady Hardinge Medical College

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractory Epilepsy

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Children on Modified Atkin Diet

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Modified Atkin Diet

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

After 3 months of diet initiation

Secondary Outcome Measure Information:

Title

Frequency of adverse effects of the modified Atkins diet.

Time Frame

3 months

Other Pre-specified Outcome Measures:

Title

Proportion of children with seizure freedom at 3 months

Time Frame

3 months

Title

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Months

Maximum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Satinder Aneja, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110001

Country

India

12. IPD Sharing Statement

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

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