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Trial record 4 of 5 for:    PLAUR

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

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ClinicalTrials.gov Identifier: NCT01880333
Recruitment Status : Completed
First Posted : June 18, 2013
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Satinder Aneja, Lady Hardinge Medical College

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.

Condition or disease Intervention/treatment Phase
Refractory Epilepsy Other: Modified Atkin Diet Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2/3 Study of the Modified Atkins Diet in Young Children With Refractory Epilepsy
Study Start Date : November 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: Children on Modified Atkin Diet 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.




Primary Outcome Measures :
  1. Proportion of children with > 50% seizure reduction at 3 months [ Time Frame: After 3 months of diet initiation ]

Secondary Outcome Measures :
  1. Frequency of adverse effects of the modified Atkins diet. [ Time Frame: 3 months ]

Other Outcome Measures:
  1. Proportion of children with seizure freedom at 3 months [ Time Frame: 3 months ]
  2. Percentage of children discontinuing diet before 3 months as per parenteral reports [ Time Frame: 3 months ]


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Ages Eligible for Study:   9 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880333


Locations
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India
Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital
New Delhi, Delhi, India, 110001
Sponsors and Collaborators
Lady Hardinge Medical College
Investigators
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Principal Investigator: Satinder Aneja, MD Kalawati Saran Children's Hospital, Lady Hardinge Medical College, New Delhi, India

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Responsible Party: Satinder Aneja, Director Professor, Lady Hardinge Medical College
ClinicalTrials.gov Identifier: NCT01880333     History of Changes
Other Study ID Numbers: MADRE
First Posted: June 18, 2013    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

Keywords provided by Satinder Aneja, Lady Hardinge Medical College:
Refractory epilepsy
dietary therapy
non-pharmacological therapy
Modified Atkin Diet

Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases