Chinese pediatric and adolescent reference intervals of vitamin E based on real-world physical examination data

Abstract

ObjectivesTo establish the reference interval (RI) of vitamin E for Chinese children and adolescents. Materials and methodsSerum tocopherol samples were examined using high performance liquid chromatography in third-party clinical laboratory institutions. Using real-world data from multi-center clinical laboratory institutions in China, the distribution parameters of vitamin E levels were described and the RI was calculated using three algorithms. ResultsA total of 756,766 cases were included in the analysis, including 435,561 males and 321,205 females. The median of vitamin E in infants younger than 4 years of age initially increased but subsequently decreased; while its levels in children between 4 and 11 years of age remained relatively stable despite progressing in age (approximately 7.4–7.8 mg/L). After the start of puberty, the difference, relative to sex, gradually became apparent, and the median vitamin E levels in females was higher than in males. The differences of vitamin E levels between different regions and samples in different seasons had no clinical significance. The RI of vitamin E for children aged 0–18 years in China was 4.5–11.1 mg/L based on expectation–maximization algorithm. The RI established by the Hoffmann method was 4.6–12.8 mg/L. ConclusionThe age- and sex-specific RIs of vitamin E were established by an indirect approach. The RIs established by EM algorithms could be used as an alternative to establish RIs based on real-world data.