protocolSection identificationModule nctId: NCT06315465, orgStudyIdInfo id: AIIMSA00647, briefTitle: Efficacy of MAD as add-on Therapy in Comparison With Standard of Care in Children With ASD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: All India Institute of Medical Sciences, New Delhi, class: OTHER, descriptionModule briefSummary: In general ketogenic diet is a recognized as an efficient non pharmacological treatment for children with refractory epilepsy. However, in the last decade, it has been tried for many neurological disorders in children including ASD, neurodegenerative disorders.Studies have shown that KD also helps in improvement of cognition, social skills, language function, and stereotypies. There is a limited number of reports of improvements after KD treatment, was insufficient evidence to attest the practicability of the KD as a treatment for ASD, but it is still a good indicator that this diet is a promising therapeutic option for this disorder. There are no major RCT's, hence raises concerns about the reliability and generalizability of findings. Majority of studies have used combined ketogenic diet therapy rather than single diet therapy and not many studies have compared add-on dietary intervention with standard of care. When compared to classic KD diet Modified Atkin's Diet is less restrictive, more palatable, more feasible and early response can be achieved. In summary, the rationale for conducting this study lies in the importance of add on dietary therapy in form of Modified Atkin's Diet along with standard of care for improvement of behavioral symptoms in children with ASD aged 3-8 years.This study aims to provide valuable insights that it can improve behavioral symptoms in ASD, early and ultimately improve the developmental outcomes in these children., conditionsModule conditions: Modified Atkins Diet, conditions: Autism Spectrum Disorder, conditions: Standard of Care, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Open Label Randomized Controlled Trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Modified Atkin's Diet with standard of care, interventions name: Standard of Care, outcomesModule primaryOutcomes measure: To evaluate the efficacy of add-on Modified Atkin's Diet therapy with standard of care as compared to standard of care alone in children with Autism Spectrum Disorder aged 3-8 years, secondaryOutcomes measure: To evaluate the efficacy of add-on Modified Atkin's Diet therapy with standard of care as compared to standard of care alone in children with Autism Spectrum Disorder aged 3-8 years, secondaryOutcomes measure: To compare the change in the cognitive ability as measured by Developmental Quotient(DQ)in children receiving Modified Atkin's Diet with standard of care vs standard of care alone in children with Autism Spectrum disorder aged 3-8 years., secondaryOutcomes measure: To compare the change in the cognitive ability as measured by Social Quotient(SQ)in children receiving Modified Atkin's Diet with standard of care vs standard of care alone in children with Autism Spectrum disorder aged 3-8 years., secondaryOutcomes measure: To compare the change in the cognitive ability as measured by Intelligence Quotient(IQ)in children receiving Modified Atkin's Diet with standard of care vs standard of care alone in children with Autism Spectrum disorder aged 3-8 years., secondaryOutcomes measure: To compare the quantitative reduction in behavioral problems using Child Behavior Checklist (CBCL) in children receiving Modified Atkin's Diet with standard of care vs standard of care alone in children with Autism Spectrum Disorder aged 3-8 years., secondaryOutcomes measure: To compare the change in sleep related problems using Children's Sleep Habit Questionnaire (CSHQ)children receiving Modified Atkin's Diet with standard of care vs standard of care alone in children with Autism Spectrum Disorder age, secondaryOutcomes measure: To compare the resting state fMRI findings in a subset of patients in the two arms, secondaryOutcomes measure: To assess the compliance in children with Autism Spectrum Disorder receiving add-on Modified Atkin's Diet with standard of care, secondaryOutcomes measure: To assess the adverse effect profile in children with Autism Spectrum Disorder receiving add-on Modified Atkin's Diet with standard of care, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False