Efficacy of MAD as add-on Therapy in Comparison With Standard of Care in Children With ASD

Summary

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.

Conditions

• Modified Atkins Diet
• Autism Spectrum Disorder
• Standard of Care

Interventions

DIETARY_SUPPLEMENT

Modified Atkin's Diet with standard of care

children who have given their consent and are randomized into Group I arm receives Modified Atkins Diet along with standard of care after completion of baseline investigations. Modified Atkin's Diet will be started in ratio of 1:1 and compliance is monitored by urine ketones. Followup will be done telephonically to check for compliance , adverse events at every 4 week intervals till 24 weeks.

OTHER

Standard of Care

Standard of care intervention plan will be devised for each subject which includes Behavioral therapy , Psychoeducation, Activity based interventions like attention enhancement exercises, self help skills, Occupational therapy, Pharmacotherapy, Sensory integration therapy. The parents of the children will be called telephonically every weekly to check for any issues and reinforcement to ensure appropriate regular behavioral intervention to be provided to the child. Physical follow up will be done every 4 weekly till 24 weeks.

Sponsors & Collaborators

• All India Institute of Medical Sciences

  lead OTHER

Principal Investigators

• Sheffali Gulati, MD · All India Institute of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

8 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-03-20

Primary Completion

2026-01-01

Completion

2026-01-01