Clinical trial NCT03764956: Comparison of Efficacy of LGIT and MAD Among Children With Drug Resistant Epilepsy
Official title: Comparison of Efficacy of Low Glycemic Index Therapy and Modified Atkins Diet Among Children With Drug Resistant Epilepsy: A Randomized Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Drug Resistant Epilepsy
Ketogenic Dieting
Keywords: MAD
LGIT
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 110
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label randomized non inferiority trial with two parallel arms
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of seizure reduction from baseline at 24 weeks of therapy
timeFrame: At the end of 24 weeks of dietary therapy
Secondary outcomes:
measure: Proportion of children who achieve >50% seizure reduction
timeFrame: At the end of 24 weeks of dietary therapy
measure: Incidence of adverse events
timeFrame: At the end of 24 weeks of dietary therapy
measure: Compliance of participants with dietary therapy in each arm will be determined each week, whether satisfactory or unsatisfactory
timeFrame: At the end of 24 weeks of dietary therapy
measure: Change in Social quotient(SQ) with each dietary therapies
timeFrame: At the end of 24 weeks of dietary therapy
measure: Change in Quality of Life of participants who are less than 4 years of age at 24 weeks as compared to baseline
timeFrame: At the end of 24 weeks of dietary therapy
measure: Change in Quality of Life of participants who are more than or equal to 4 years of age at 24 weeks as compared to baseline
timeFrame: At the end of 24 weeks of dietary therapy
measure: Change in Quality of Life of caregivers at 24 weeks as compared to baseline
timeFrame: At the end of 24 weeks of dietary therapy
measure: Gut microbiota (GM) analysis pre and post dietary therapy
timeFrame: At the end of 24 weeks of dietary therapy
measure: Change in behavioral abnormalities with each dietary therapy
timeFrame: At the end of 24 weeks of dietary therapy
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
city: New Delhi
country: India
facility: AIIMS
state: Delhi
Study officials:
affiliation: All India Institute of Medical Sciences
name: Sheffali Gulati, MD
role: PRINCIPAL_INVESTIGATOR
References: