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临床试验/CTRI/2025/07/091110
CTRI/2025/07/091110
尚未招募
不适用

Nutritional assessment and dietary intervention for children (3- 10 years) with Autism Spectrum Disorder

Madhumita Rajendraprasad1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2025年8月4日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Madhumita Rajendraprasad
入组人数
210
试验地点
1
主要终点
1. Change in ATEC score (total and domain-wise) before and after 3 months of dietary intervention.

概览

简要总结

This prospective interventional study aims to evaluate the impact of tailored dietary interventions on autism symptomatology and nutritional status in children aged 3 to 10 years diagnosed with Autism Spectrum Disorder. A total of 110 children will be enrolled. At baseline, participants will undergo comprehensive assessments, including anthropometric measurements, dietary intake analysis, biochemical parameters, and a clinical evaluation, to determine their nutritional status. Autism related behaviors will be assessed using standardized tools, such as the Autism Treatment Evaluation Checklist (ATEC) and the Brief Autism Mealtime Behavior Inventory (BAMBI). Food intolerances will be identified using an elimination diet approach, and individualized nutrition plans will be developed based on these findings. The intervention will be implemented over a period of 3 months after which post-intervention assessments will be conducted. The primary outcome is the change in ATEC scores before and after the dietary intervention reflecting the effect of nutrition on autism symptomatology. Secondary outcomes include changes in BAMBI scores, improvements in nutritional status, dietary adequacy, the incidence of Avoidant Restrictive Food Intake Disorder ARFID, and correlations between food intolerances and autism severity. Findings from the study aim to establish evidence based dietary strategies for children with ASD and promote knowledge transfer to caregivers and the broader community enabling sustainable nutrition management and improved quality of life.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
3.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Children diagnosed with ASD based on ISAA between the age group of 3-10 years Either gender Recruited with written informed consent.

排除标准

  • Diagnosis of Asperger syndrome, Rett syndrome or any other congenital disease Chronic seizures or an acute or chronic affective disease during the past three months.

结局指标

主要结局

1. Change in ATEC score (total and domain-wise) before and after 3 months of dietary intervention.

时间窗: 1. Time Points: Baseline and 3 months post-intervention

次要结局

  • 1. Change in BAMBI scores indicating mealtime behavior improvement.(2. Incidence and pattern of food intolerances and ARFID among enrolled children.)

研究者

发起方
Madhumita Rajendraprasad
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Madhumita Rajendraprasad

National Institute of Physical Medicine and Rehabilitation

研究点 (1)

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