Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dietary Therapy In Epilepsy Treatment (DIET-Trial): A Randomised Non Inferiority Trial Comparing KD, MAD & LGIT for Drug Resistant Epilepsy (DIET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02708030
Recruitment Status : Unknown
Verified July 2017 by Sheffali Gulati, All India Institute of Medical Sciences, New Delhi.
Recruitment status was:  Active, not recruiting
First Posted : March 15, 2016
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
Sheffali Gulati, All India Institute of Medical Sciences, New Delhi

Brief Summary:

This randomised trial is undertaken to assess whether MAD or LGIT is non-inferior to KD with regard to seizure control at twenty-four weeks among children with drug resistant epilepsy. The hypothesis of the study is that in 1 to 15-year-old children with drug resistant epilepsy, use of Modified Atkins Diet (MAD) or Low Glycemic Index Therapy (LGIT) as an add on to the ongoing anti-epileptic drugs would not be inferior to ketogenic diet by >15% in terms of seizure reduction from baseline seizure frequency at 24 weeks.

The primary outcome of the study is to determine the efficacy of MAD as compared to KD and LGIT as compared to KD for seizure reduction in drug resistant epilepsy following 24 weeks of dietary therapy in 1 to 15-year-old children on anti-epileptic drugs. The change in seizure frequency will be estimated as percentage change in seizure reduction at 24 weeks as compared to baseline.


Condition or disease Intervention/treatment Phase
Drug Resistant Epilepsy Other: Ketogenic Diet Other: MAD Other: LGIT Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Ketogenic Diet, Modified Atkins Diet and Low Glycemic Index Therapy Diet Among Children With Drug Resistant Epilepsy: A Randomised Non-Inferiority Trial
Study Start Date : April 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
Active Comparator: Ketogenic Diet
Ketogenic diet (KD) will be administered by the non-fasting protocol. The child will be admitted to the hospital, and KD will be started in 1:1 ratio. The ratio will increased every 48hours to a maximum of 4:1 or ketosis (urinary ketones 40-80mg/dL) is attained. The child will thereafter be discharged and followed up on Out patient basis.
Other: Ketogenic Diet
The children with the drug resistant epilepsy will go through a run in period of 4 weeks during which each child will undergo a detailed detailed clinical evaluation according to a structured proforma, and baseline investigations. The patients in KD arm will be admitted to the hospital for initiation of diet.

Experimental: Modified Atkins Diet
Modified Atkins Diet (MAD) will be administered on out patient basis. Parents of children will be advised to monitor for seizure frequency and ketosis at home.
Other: MAD
The children with the drug resistant epilepsy will go through a run in period of 4 weeks during which each child will undergo a detailed detailed clinical evaluation according to a structured proforma, and baseline investigations. Following the run in period of 4 weeks, the patients will be randomized to the MAD or LGIT or KD arm. MAD will be initiated on out patient basis.

Experimental: Low Glycemic Index Therapy
Low Glycemic Index Therapy (LGIT) will be administered on out patient basis. Parents of children will be advised to monitor for seizure frequency and ketosis at home.
Other: LGIT
The children with the drug resistant epilepsy will go through a run in period of 4 weeks during which each child will undergo a detailed detailed clinical evaluation according to a structured proforma, and baseline investigations. Following the run in period of 4 weeks, the patients will be randomized to the MAD or LGIT or KD arm. LGIT will be initiated on out patient basis.




Primary Outcome Measures :
  1. Percentage change in seizure frequency after 24 weeks of dietary therapy as compared to baseline, in the arm KD as compared to MAD and in the arm KD as compared to LGIT [ Time Frame: Baseline and six months ]

    Percentage change in seizure frequency will be estimated as mean number of weekly seizures over preceding 4 weeks after 24 weeks of dietary therapy divided by mean number of weekly seizures over preceding 4 weeks at the baseline.

    It will be calculated for each of the three arms (KD; MAD; LGIT) and KD will compared to MAD and LGIT individually as the primary outcome.



Secondary Outcome Measures :
  1. Percentage change in seizure frequency after 24 weeks of dietary therapy as compared to baseline, in the arm MAD as compared to LGIT [ Time Frame: Baseline and twenty-four weeks ]
    Percentage change in seizure frequency will be estimated as mean number of weekly seizures over preceding 4 weeks after 24 weeks of dietary therapy divided by mean number of weekly seizures over preceding 4 weeks at the baseline. Change in seizure frequency in MAD and LGIT arm will be compared

  2. Proportion of patients who achieve >50% seizure reduction from baseline at 24 weeks after diet initiation [ Time Frame: Baseline and twenty-four weeks ]
    Proportion of patients who achieve >50% seizure reduction from baseline at 24 weeks after diet initiation

  3. Estimate behavior change as measured by Childhood behavior checklist in each of three arms at baseline, 12 weeks and 24 weeks after dietary therapy [ Time Frame: Baseline, twelve weeks, and twenty-four weeks ]
  4. Estimate cognition change as assessed by Vineland Social Maturity Scale in each of three arms at baseline, 12 weeks and 24 weeks after dietary therapy [ Time Frame: Baseline and twenty-four weeks ]
  5. Evaluate GI adverse events (diarrhoea, constipation and vomiting) assessed by parental questionnaire in each of the three arms at baseline and six months after therapy [ Time Frame: Baseline and twenty-four weeks ]
  6. Evaluate change in serum levels of micronutrients by laboratory testing in each of three arms at baseline and six months after therapy [ Time Frame: Baseline and twenty-four weeks ]
    Micronutrients like copper, zinc, retinol and vitamin E would be compared

  7. Evaluate omega3 polyunsaturated fatty acid levels and correlate it with change in seizure frequency [ Time Frame: Baseline and twenty-four weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children aged 1-15 years with drug resistant epilepsy (Drug resistant epilepsy for the study will be defined as seizure frequency >4 seizures per month, and treatment failure of ≥2 prescribed antiepileptic drugs).
  2. Willing to come for regular follow up

Exclusion Criteria:

  1. Surgically remediable cause for drug resistant epilepsy
  2. Proven inborn error of metabolism except those in which KD is indicated (i.e., Pyruvate Carboxylase deficiency and GLUT-1 Deficiency)
  3. Previously received KD, MAD or LGIT
  4. Known case of

    1. Chronic kidney disease
    2. Chronic liver disease/ GI illness
    3. Chronic heart disease (congenital and acquired)
    4. Chronic respiratory illness

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): NCT02708030


Locations
Layout table for location information
India
All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi

Layout table for additonal information
Responsible Party: Sheffali Gulati, Professor, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT02708030    
Other Study ID Numbers: KD Vs MAD Vs LGIT
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases