DR. KOUSALYA K S,DR. LAL DEVAYANI VASUDEVAN NAIR,DR. SWARNA PRIYA

DOI: https://doi.org/

Background: Autism spectrum disorder (ASD) is a complex neurodevelopmental condition with multifactorial etiology, including possible disruptions in folate metabolism.Objective: To evaluate the effectiveness of Quatre Folic supplementation in reducing the severity of autistic symptoms in children under five years of age, as measured by pre- and post-intervention CARS-II scores.Methods: This study was designed as a single-centre, hospital-based, prospective, parallel-group, double-blinded, randomized controlled trial conducted in the Department of Paediatrics at Saveetha Institute of Medical and Technical Sciences, Chennai, over a period of five months from January to May 2025.Results: The baseline characteristics of participants in the Quatre Folic (QF) and Standard Treatment (ST) groups were comparable in terms of age, gender distribution, anthropometric measures, haemoglobin levels, and CARS-II scores, indicating well-balanced groups. After 12 weeks of intervention, the QF group exhibited a significantly greater reduction in autism severity, with a mean decrease in CARS-II score of 3.02 ± 1.17 compared to 1.05 ± 0.75 in the ST group (p < 0.001). The post-intervention mean CARS-II score in the QF group was 29.82 ± 1.89, significantly lower than the ST group’s 32.36 ± 1.76 (p = 0.001), reflecting meaningful clinical improvement. The QF group also showed a significant increase in haemoglobin levels from 11.57 ± 0.90 to 11.77 ± 0.80 g/dL, whereas the ST group remained unchanged (11.13 ± 1.10 to 11.12 ± 1.13 g/dL), with a between-group mean difference of 0.22 g/dL (p = 0.003). Changes in weight-for-age Z-scores were minimal, with the QF group improving from −1.05 ± 0.93 to −0.97 ± 0.94, while the ST group slightly declined from −0.55 ± 0.77 to −0.57 ± 0.79; however, this difference was not statistically significant (p = 0.182).Conclusion: Quatre Folic supplementation significantly reduced autism severity and improved haemoglobin levels in children under five with mild to moderate ASD. These findings support its potential as an effective adjunctive therapy in early autism management.