Comparison of Efficacy of LGIT and MAD Among Children With Drug Resistant Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-26

Study Completion Date

2019-12-31

Brief Summary

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To compare the efficacy of two less restrictive dietary therapies - LGIT and MAD, used for treatment of drug resistant epilepsy in children

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Detailed Description

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Up to one third of patients with epilepsy progress to drug resistant epilepsy (DRE). Current treatment options for DRE include epileptic surgery and dietary therapy. Classic KD (Ketogenic diet) is the most studied dietary therapy but the stringent restrictions and practical difficulty makes it difficult to follow. So less restrictive diets like MAD and LGIT were introduced. These are reported to have less adverse effects also. But no published study has ever been conducted comparing these two diets head to head.

Conditions

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Drug Resistant Epilepsy Ketogenic Dieting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open label randomized non inferiority trial with two parallel arms

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low Glycemic Index therapy

Specific dietary therapy called Low glycemic Index Therapy (LGIT) which provides diet including food items with glycemic index less than 50 only

Group Type EXPERIMENTAL

Low glycemic Index Therapy (LGIT)

Intervention Type OTHER

Specific dietary therapy called Low glycemic Index Therapy (LGIT) which provides diet including food items with glycemic index less than 50 only. For this purpose, various dietary menus will be provided to the parents.

Modified Atkins Diet

Specific dietary therapy called Modified Atkins Diet (MAD) which provides diet with restricted carbohydrates upto 20 grams per day and increased fat and protein ratio

Group Type ACTIVE_COMPARATOR

Modified Atkins Diet (MAD)

Intervention Type OTHER

Specific dietary therapy called Modified Atkins Diet (MAD) which provides diet with restricted carbohydrates upto 20 grams per day and increased fat and protein ratio. For this purpose, various dietary menus will be provided to the parents.

Interventions

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Low glycemic Index Therapy (LGIT)

Specific dietary therapy called Low glycemic Index Therapy (LGIT) which provides diet including food items with glycemic index less than 50 only. For this purpose, various dietary menus will be provided to the parents.

Intervention Type OTHER

Modified Atkins Diet (MAD)

Specific dietary therapy called Modified Atkins Diet (MAD) which provides diet with restricted carbohydrates upto 20 grams per day and increased fat and protein ratio. For this purpose, various dietary menus will be provided to the parents.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children aged 1-15 years with drug resistant epilepsy
* Willing to come for regular follow-up according to study protocol Drug resistant epilepsy defined as
* Seizure frequency \>4 seizures per month, while on optimal doses of at least 2 prescribed antiepileptic drugs
* For West syndrome, drug resistant epilepsy will be defined as more than 4 clusters of spasms per month despite treatment with antiepileptic drugs and either ACTH(Adrenocorticotrophic hormone) or Vigabatrin

Exclusion Criteria

* Surgically remediable causes for DRE
* Inborn errors of metabolism
* Previously received KD, MAD or LGIT
* Known case of

1. Chronic kidney disease
2. Chronic liver disease/GI illness
3. Congenital/acquired heart disease
4. Chronic respiratory illness

Minimum Eligible Age

1 Year

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No