The 12 weeks, randomized, double-blinded, placebo-controlled human study to evaluate the effectiveness and safety of KGC deer antlers on the growth of children.

BACKGROUND: Cervi parvum cornu is a dried section of the young horns of Cervus nippon Temminck, Cervus elaphus Linnaeus, or Cervus canadensis Erxleben. It is a representative yang-tonifying medicine that warms the viscera and bowels, activates the overall physiological function, and has effects such as tonifying kidney yang, replenishing essence and blood, and strengthening muscles and bones. OBJECTIVE: This clinical study is aimed to evaluate the effectiveness of deer antler extract on child growth. METHODS: This clinical trial is designed to be conducted on 100 children aged 3 to 12 years for 12 weeks (Trial registration code: KCT0007386). We will evaluate changes in height, height percentile, standard deviation score of height, weight, body mass index, waist circumference, hip circumference, bone age, predicted adult height estimated by bone age, human growth hormone level, insulin-like growth factor-1 (IGF-1) level, IGF-binding protein-3 (IGFBP-3) level, IGF-1/IGFBP-3 ratio, and estradiol level. Additionally, we also will evaluate the adverse events during the study.