Abstract
This randomized, double-blind, placebo-controlled clinical trial evaluated the efficacy and safety of fermented oyster extract (FGO) as a functional food ingredient for promoting growth in children with idiopathic short stature (ISS). In total, 80 children aged 6－9 years with height below the 25th percentile for age and gender per the Korean National Growth Charts, 2017, were included. They were randomly assigned to receive either 500 mg/d FGO or a matched placebo for 24 weeks. The primary outcome was a change in height while standing; secondary outcomes included growth rate, height standard deviation score (height-SDS), bone age (BA), and levels of growth-related hormones and bone metabolism markers. In the intention-to-treat analysis, mean height gain at 24 weeks was 3.22±0.71 and 2.38±0.74 cm in the FGO and placebo groups (P<0.001). Growth rate, height-SDS, BA, serum insulin-like growth factor-1, and urinary deoxypyridinoline increased significantly in the FGO group compared with the placebo group (P<0.05). In contrast, growth hormone and insulin-like growth factor-binding protein-3 levels did not vary between groups. No serious adverse events or clinically meaningful laboratory abnormalities were observed; however, two events of mild rash, possibly related to FGO, led to one drop-out. These findings suggest that standardized FGO may safely augment linear growth and bone metabolism in children with ISS. This product could be developed as a marine-derived functional food for pediatric growth support, although more long-term and multicenter studies are warranted to confirm the generalizability of these effects and FGO durability.