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

NCT06315465 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: AIIMSA00647
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Modified Atkin's Diet; Autism Spectrum Disorder; Standard of care

Outcome Measures

Primary Outcomes (1)

• 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

  Proportion of children with minimum significant reduction of Childhood Autism Rating Scale (CARS-2) score (defined by ≥ 4.5 reduction) in both arms. Childhood Autism Rating Scale is an evaluation tool used for identifying autism and determining the severity of autism spectrum disorder. It can be used in children 2 years and older with Autism Spectrum Disorder. It contains total 15 domains and each domain have score from 0-4. Total score 15 to 60 and total score of less than 30 indicates non autism, 30-36.5 indicates mild to moderate autism, 37-60 is considered as severe autism

  3 months

Secondary Outcomes (9)

• 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

  6 months

• 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.

  6 months

• 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.

  6 months

• 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.

  6 months

• 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.

  6 months

Study Arms (2)

Modified Atkin's diet with standard of care arm

EXPERIMENTAL

Group I will receive Modified Atkin's Diet with standard of care whereas Group II will receive standard of care alone. Children randomized into Group I, initial workup for Modified Atkin's Diet will be done in the form of Electrocardiogram, Renal Function Tests, Liver Function Tests, Complete Blood Counts, Lipid profile, Urine calcium creatinine ratio and Ultrasound Pelvis for nephrocalcinosis. If pre KD work up is normal, then Modified Atkin's Diet will be initiated in the ratio of 1:1.Urine ketones will be checked daily using ketone dipsticks. Telephonic contacts will be made in regular intervals every week to further ensure compliance at home, and to ensure proper understanding and confidence of parents. Those children who are unable to tolerate taking adequate ketogenic diet therapy requiring discontinuation of therapy, will be considered as deviates. First follow-up will be at 4 weeks of treatment initiation, followed by at 8, 12, 16, 20 and 24 weeks.

Dietary Supplement: Modified Atkin's Diet with standard of care; Other: Standard of Care

Standard of care arm

OTHER

* Standard of care intervention plan will be devised for each subject based on the principles of - * Behavioral therapy 1. Behavioral modification techniques 2. Psycho education 3. Cognitive behavioral therapy 4. Activity based interventions like eye contact exercises, attention enhancement exercises, self-help skills 5. Speech therapy 6. Parental training * Occupational therapy * Sensory integration therapy * Pharmacotherapy - Anti-psychotic medications * The parents of the children will be called telephonically every weekly to check for any issues and reinforcement to ensure appropriate regular behavioural intervention to be provided to the child. * Physical follow up - 4, 8, 12, 16, 20, 24 weeks * Follow up assessments - 12 weeks (3 months) \& 24 weeks (6 months)

Other: Standard of Care

Interventions

Modified Atkin's Diet with standard of care DIETARY_SUPPLEMENT

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.

Modified Atkin's diet with standard of care arm

Standard of Care OTHER

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.

Modified Atkin's diet with standard of care arm; Standard of care arm

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \. Children aged 3 to 8 years diagnosed with Autism Spectrum Disorder according to DSM -V criteria

You may not qualify if:

• Diagnosed genetic and metabolic syndromes
• Pre-existing food fads
• Associated seizure disorder/epilepsy syndrome
• Chronic systemic illness
• Received any form of dietary therapy in the previous 6 months
• Not on stable standard of care therapy or changes in antipsychotic medications over the last 1 month
• Refusal of consent

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sheffali Gulati, MD

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheffali Gulati, MD

CONTACT

01126594679; sheffaligulati@gmail.com

Sheffali Gulati, MD

CONTACT

9810386847; sheffaligulati1@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Open Label Randomized Controlled Trial

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 18, 2024
• Study Start: March 20, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: March 18, 2024

Record last verified: 2024-03