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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03764956
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Sheffali Gulati, All India Institute of Medical Sciences, New Delhi

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

Condition or disease Intervention/treatment Phase
Drug Resistant Epilepsy Ketogenic Dieting Other: Low glycemic Index Therapy (LGIT) Other: Modified Atkins Diet (MAD) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open label randomized non inferiority trial with two parallel arms
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 26, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: 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
Other: 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.

Active Comparator: 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
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.




Primary Outcome Measures :
  1. Percentage of seizure reduction from baseline at 24 weeks of therapy [ Time Frame: At the end of 24 weeks of dietary therapy ]
    Mean weekly seizure reduction at 24 weeks divided by Mean weekly seizure measured at baseline multiplied by 100


Secondary Outcome Measures :
  1. Proportion of children who achieve >50% seizure reduction [ Time Frame: At the end of 24 weeks of dietary therapy ]
    Number of children with >50% reduction divided by number of children in each arm

  2. Incidence of adverse events [ Time Frame: At the end of 24 weeks of dietary therapy ]
    Routine hemogram, Renal function test (RFT), Liver function test (LFT) and lipid profile will be assessed for any alterations. Adverse events, vomiting, constipation and diarrhea will be checked by parents record

  3. Compliance of participants with dietary therapy in each arm will be determined each week, whether satisfactory or unsatisfactory [ Time Frame: At the end of 24 weeks of dietary therapy ]
    Weekly compliance assessment of each participant will be done

  4. Change in Social quotient(SQ) with each dietary therapies [ Time Frame: At the end of 24 weeks of dietary therapy ]
    Proportion of children with improvement in Social quotient (SQ) assessed by Vineland Social Maturity Scale (VSMS) at 24 weeks. VSMS consists of 8 subsets - Communication skills, General self-help ability, Locomotion skills, Occupation skills, Self-direction, Self-help eating, Self-help dressing, Socialization skills. Social age is calculated by adding the scores of all subsets. Social quotient (SQ) is calculated by social age divided by chronological age multiplied by 100.

  5. Change in Quality of Life of participants who are less than 4 years of age at 24 weeks as compared to baseline [ Time Frame: At the end of 24 weeks of dietary therapy ]
    In children less than 4 years quality of life is assessed by PedsQL (Pediatric Quality of life inventory). PedsQL consists of 21 questions each having 5 responses with scores 0,1,2,3 and 4. Minimum score is 0 and maximum is 84. Quality of life is poor with larger score.

  6. 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 [ Time Frame: At the end of 24 weeks of dietary therapy ]
    In children with age 4 years or more, QOLCE 55 (Quality of life in childhood epilepsy questionnaire) is used to assess quality of life. QOLCE 55 consists of 55 questions which are classified into 4 categories. Each question have 5 responses with scores as 0,25,50,75 and 100. Mean score of each category is calculated and final score calculated by mean of the scores of 4 categories. Minimum score is 0 and maximum is 100. Quality of life is better with larger score.

  7. Change in Quality of Life of caregivers at 24 weeks as compared to baseline [ Time Frame: At the end of 24 weeks of dietary therapy ]
    Quality of life of caregivers is assessed by WHOQOL-BREF. WHOQOL BREF contains 26 items categorized into 4 domains. For each question response is scored 1,2,3,4 or 5. Total raw score is then calculated and is converted to transformed score. Minimum score is 0 and maximum is 100. Quality of life is poor with smaller score.

  8. Gut microbiota (GM) analysis pre and post dietary therapy [ Time Frame: At the end of 24 weeks of dietary therapy ]
    Changes in percentage distribution of various micro organisms in gut microbiota after dietary therapy as compared to baseline GM

  9. Change in behavioral abnormalities with each dietary therapy [ Time Frame: At the end of 24 weeks of dietary therapy ]
    Behavior assessment is done using Child behavior check list (CBCL).This questionnaire contains 100 and 113 questions for age groups of 1 ½ - 5 years and 6-18 years respectively. Score of 2 will be given for a response of 'very true', 1 for a response of 'somewhat true' and 0 for 'not true'. Total score is obtained by adding all the subsets. Subsets for age 1.5 years to 5 years include - Emotionally reactive, anxious/depressed, somatic complaints, withdrawn, sleep problems, attention problems, aggressive behavior and other problems. Subsets for age 6 years to 12 years include - Anxious/Depressed, withdrawn, somatic complaints, social problems, thought problems, attention problems, rule breaking behavior, aggressive behavior, other problems. Raw score is then converted to T score according to the published charts. Minimum T score is 28 and maximum is 100. Larger score indicates more behavioral problems.



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Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03764956


Contacts
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Contact: Sheffali Gulati, MD 9810386847 sheffaligulati@gmail.com
Contact: Vaishakh Anand, MD 7838528549 drvyshakhanandmp@gmail.com

Locations
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India
All India Institute of Medical Sciences Recruiting
New Delhi, Delhi, India, 110029
Contact: Gulati Sheffali, MD    9868397532    sheffaligulati@gmail.com   
Principal Investigator: Gulati Sheffali, MD         
AIIMS Recruiting
New Delhi, Delhi, India
Contact: Sheffali Gulati, M.D.    26594679 ext 011    sheffaligulati@gmail.com   
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
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Principal Investigator: Sheffali Gulati, MD All India Institute of Medical Sciences, New Delhi

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Responsible Party: Sheffali Gulati, Professor, Chief, Child Neurology Division, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT03764956    
Other Study ID Numbers: IECPG/504/10/2018
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sheffali Gulati, All India Institute of Medical Sciences, New Delhi:
MAD
LGIT
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases