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

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)

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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)