A Clinical Investigation on the Safety and Effectiveness of Dietary Supplements: Curcumin, Vitamin C, and Vitamin B Complex Gummies in Paediatric Health

Background: Gummies offer a novel supplement delivery method appealing to children. This study investigates the safety, efficacy, and organoleptic properties of three distinct gummies— Curcumin Gummies, Vitamin-B-complex Gummies, and Vitamin-C Gummies in paediatric health. Methods: A 30-day open-label, three-arm, parallel design study with 48 children assessed the efficacy, safety, and organoleptic properties of the gummies. Subjects were randomized to receive one of the gummies. Endpoints included sickness frequency, Quality-of-Life hedonic questionnaires. Statistical analysis was done using SPSS software (Version:26.0). Adherence to ICH-GCP, Declaration of Helsinki, ICMR guidelines, and NDCT Rules, was maintained. Results: In this study, significant improvements were observed across all groups post-supplementation. Prior to intake, subjects reported low energy levels and sickness. Post-supplementation, all subjects reported excellent health, heightened energy levels, calmness and peace. Positive feedback on organoleptic properties further supported the acceptability of the gummies. Further, no adverse event was reported. Conclusions: This study highlights gummy supplements' clinical efficacy, safety, and palatability. Essential ingredients like Curcumin, Vitamin B Complex, and Vitamin C make them optimal for children's nutritional needs. The delightful taste and convenient form of Noochy™️ gummies ensured high subjects’ compliance. The absence of adverse events emphasizes their safety profile. This research contributes to paediatric vitamin supplementation, showcasing gummies' potential for promoting comprehensive well-being in children.