A Phase 4 interventional study of Low glycemic Index Therapy (LGIT) and Modified Atkins Diet (MAD) in Drug Resistant Epilepsy and Ketogenic Dieting, sponsored by All India Institute of Medical Sciences, New Delhi. Status unknown at 2 sites in India. Open to participants aged 1 Year to 15 Years. Per ClinicalTrials.gov, last updated 2019-09-10.
Sponsored by All India Institute of Medical Sciences, New Delhi · Phase 4, Interventional, and Treatment
To compare the efficacy of two less restrictive dietary therapies - LGIT and MAD, used for treatment of drug resistant epilepsy in children
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's planned enrollment of 110 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →All India Institute of Medical Sciences, New Delhi is the lead sponsor of 146 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Known case of
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 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 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.
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.
Percentage of seizure reduction from baseline at 24 weeks of therapy
Mean weekly seizure reduction at 24 weeks divided by Mean weekly seizure measured at baseline multiplied by 100
Time frame: At the end of 24 weeks of dietary therapy
Proportion of children who achieve >50% seizure reduction
Number of children with \>50% reduction divided by number of children in each arm
Time frame: At the end of 24 weeks of dietary therapy
Incidence of adverse events
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
Time frame: At the end of 24 weeks of dietary therapy
Compliance of participants with dietary therapy in each arm will be determined each week, whether satisfactory or unsatisfactory
Weekly compliance assessment of each participant will be done
Time frame: At the end of 24 weeks of dietary therapy
Change in Social quotient(SQ) with each dietary therapies
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.
Time frame: At the end of 24 weeks of dietary therapy
Change in Quality of Life of participants who are less than 4 years of age at 24 weeks as compared to baseline
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.
Time frame: At the end of 24 weeks of dietary therapy
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
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.
Time frame: At the end of 24 weeks of dietary therapy
Change in Quality of Life of caregivers at 24 weeks as compared to baseline
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.
Time frame: At the end of 24 weeks of dietary therapy
Gut microbiota (GM) analysis pre and post dietary therapy
Changes in percentage distribution of various micro organisms in gut microbiota after dietary therapy as compared to baseline GM
Time frame: At the end of 24 weeks of dietary therapy
Change in behavioral abnormalities with each 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.
Time frame: At the end of 24 weeks of dietary therapy
Plan to share: Undecided
No publications or documents are linked to this record.
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All India Institute of Medical Sciences, New Delhi