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

A

All India Institute Of Medical Science (AIIMS)

Status and phase

Unknown
Phase 4

Conditions

Drug Resistant Epilepsy
Ketogenic Dieting

Treatments

Other: Low glycemic Index Therapy (LGIT)
Other: Modified Atkins Diet (MAD)

Study type

Interventional

Funder types

Other

Identifiers

NCT03764956
IECPG/504/10/2018

Details and patient eligibility

About

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

Full description

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.

Enrollment

110 estimated patients

Sex

All

Ages

1 to 15 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

110 participants in 2 patient groups

Low Glycemic Index therapy
Experimental group
Description:
Specific dietary therapy called Low glycemic Index Therapy (LGIT) which provides diet including food items with glycemic index less than 50 only
Treatment:
Other: Low glycemic Index Therapy (LGIT)
Modified Atkins Diet
Active Comparator group
Description:
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
Treatment:
Other: Modified Atkins Diet (MAD)

Trial contacts and locations

2

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Central trial contact

Sheffali Gulati, MD; Vaishakh Anand, MD

Data sourced from clinicaltrials.gov

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