Drug Resistant EpilepsyPhase 4NCT03764956
Comparison of Efficacy of LGIT and MAD Among Children With Drug Resistant Epilepsy
A Phase 4 study testing Low glycemic Index Therapy (LGIT) and Modified Atkins Diet (MAD) in people with Drug Resistant Epilepsy and Ketogenic Dieting, run by All India Institute of Medical Sciences at 2 sites in India.
Trial summary
To compare the efficacy of two less restrictive dietary therapies - LGIT and MAD, used for treatment of drug resistant epilepsy in children Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Drug Resistant Epilepsy, Ketogenic Dieting
- What is being tested?
- Low glycemic Index Therapy (LGIT) and Modified Atkins Diet (MAD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesIndia
- Study dates
- 26 Dec 2018to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Surgically remediable causes for DRE
- Inborn errors of metabolism
- Previously received KD, MAD or LGIT
- Known case of
- Chronic kidney disease
- Chronic liver disease/GI illness
- Congenital/acquired heart disease
- Chronic respiratory illness
Trial locations and contacts
2 sites in 1 country.
India2 sites, 2 recruiting
- Recruiting
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
Gulati Sheffali, MD, 9868397532, sheffaligulati@gmail.com
Gulati Sheffali, MD
- Recruiting
AIIMS
New Delhi, National Capital Territory of Delhi
Sheffali Gulati, M.D., 26594679 ext. 011, sheffaligulati@gmail.com
About this study
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
To compare the efficacy of two less restrictive dietary therapies - LGIT and MAD, used for treatment of drug resistant epilepsy in children
Read the 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.
- Conditions
- Drug Resistant Epilepsy, Ketogenic Dieting
- Being tested
- Low glycemic Index Therapy (LGIT), Modified Atkins Diet (MAD)
- Keywords
- MAD, LGIT
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycemic Index Therapy (LGIT)Other
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.
Modified Atkins Diet (MAD)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Glycemic Index therapy | Experimental | Specific dietary therapy called Low glycemic Index Therapy (LGIT) which provides diet including food items with glycemic index less than 50 only Receives: Other: Low glycemic Index Therapy (LGIT) |
| Modified Atkins Diet | Active comparator | 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 Receives: Other: Modified Atkins Diet (MAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the end of 24 weeks of dietary therapy
Secondary outcomes (9)
Proportion of children who achieve >50% seizure reduction
Number of children with >50% reduction divided by number of children in each arm
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: At the end of 24 weeks of dietary therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start26 Dec 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label randomized non inferiority trial with two parallel arms
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheffali Gulati, All India Institute of Medical Sciences
- Investigators
- Sheffali Gulati, MD, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764956
- Sponsor's protocol ID
- IECPG/504/10/2018
- Status last verified
- Sep 2019
- First submitted
- 4 Nov 2018
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03764956
- Acronym / sponsor ID
- IECPG/504/10/2018
- Conditions
- Drug Resistant Epilepsy, Ketogenic Dieting
- Keywords
- MAD, LGIT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 26 Dec 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label randomized non inferiority trial with two parallel arms
| Arm | Type | Receives |
|---|---|---|
| Low Glycemic Index therapy | Experimental | 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 |
| Modified Atkins Diet | Active comparator | 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 |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Surgically remediable causes for DRE
- Inborn errors of metabolism
- Previously received KD, MAD or LGIT
- Known case of
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Low Glycemic Index therapy |
| 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. | Other | Modified Atkins Diet |
Primary outcome
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
9 secondary outcomes
Proportion of children who achieve >50% seizure reduction
Time frame: At the end of 24 weeks of dietary therapy
Incidence of adverse events
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
Time frame: At the end of 24 weeks of dietary therapy
Change in Social quotient(SQ) with each dietary therapies
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
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
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
Time frame: At the end of 24 weeks of dietary therapy
Gut microbiota (GM) analysis pre and post dietary therapy
Time frame: At the end of 24 weeks of dietary therapy
Change in behavioral abnormalities with each dietary therapy
Time frame: At the end of 24 weeks of dietary therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheffali Gulati, MD principal investigator
All India Institute of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low glycemic Index Therapy (LGIT) and Modified Atkins Diet (MAD) in people with Drug Resistant Epilepsy and Ketogenic Dieting, run by All India Institute of Medical Sciences at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheffali Gulati, MD (9810386847, sheffaligulati@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of seizure reduction from baseline at 24 weeks of therapy (time frame: At the end of 24 weeks of dietary therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.