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Taurine supplementation in children with autism spectrum disorders: a study protocol for an exploratory randomized,
Yun Chen1,2, Wennan He3, Qun Deng1,2
1Department of Pediatrics, Guizhou Provincial People's Hospital, Guiyang, Guizhou Province, 550000, China.
Insights
This study investigates if taurine supplements can improve core symptoms in children with Autism Spectrum Disorder (ASD). It
Area of Science:
- Neuroscience
- Developmental Pediatrics
- Nutritional Science
Background:
- Autism Spectrum Disorder (ASD) is a common neurodevelopmental disorder with limited treatment options.
- Nutritional interventions show promise for improving ASD core symptoms.
- Children with ASD often exhibit lower taurine levels, suggesting a potential role for this amino acid.
Purpose of the Study:
- To evaluate the efficacy of daily taurine supplementation in improving core symptoms of ASD.
- To explore the potential clinical application and safety of taurine for ASD.
Main Methods:
- An exploratory randomized, double-blind, placebo-controlled trial involving 60 children with ASD.
- Participants will receive daily oral taurine or placebo for 3 months, alongside behavioral treatment.
- Follow-up assessments will occur at multiple time points up to 12 months, focusing on ASD-specific questionnaires.
Main Results:
- This section is not yet available as the trial is ongoing.
Conclusions:
- This is the first randomized controlled trial to assess daily taurine supplementation for ASD core symptoms.
- The study aims to determine if taurine supplementation is an effective and safe clinical option for ASD.
Background:
ASD is the most common neurodevelopment dysfunction and disabling disorder in childhood, with a lack of specific clinical treatment methods. Evidence-based study reveals that nutrients supplement can improve the core symptom of ASD. Our previous study demonstrated the children with ASD were found to have lower taurine levels in serum and urine samples. However, whether or not the taurine supplementation can improve the core symptom of ASD is unclear.
Methods:
This is an exploratory randomized, double-blind, placebo-controlled trial. Sixty children with ASD will be randomly allocated to receive daily taurine supplementation (taking orally with the recommended dose) or placebo in a 1:1 ratio for 3 months. All children will receive behavioral treatment throughout the study period. All researchers, participants and their caregivers will be blinded until the completion of data analysis, and randomization and allocation will be fully concealed from all mentioned parties. Follow-up will be conducted at the baseline, 1st month, 2nd month, 3rd month, 6th month, 9th month and 12th month. The primary outcomes will focus on changes in scores of ASD-specific questionnaires.
Discussion:
To our knowledge there are no randomized controlled trials assessing the effects of daily taurine supplementation on the core symptoms of ASD. This trial would help evaluate the efficacy of taurine supplementation on ASD, and initially explore if its potential value on clinical application outweighs the risk.
Trial Registrations:
ClinicalTrials Registry NCT05980520. Registered on July 31, 2023.
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