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Effects of Astragalus Extract Mixture HT042 on Height Growth in Children with Mild Short Stature: A Multicenter Randomized Controlled Trial
Author(s) -
Lee Donghun,
Lee Sun Haeng,
Song Jungbin,
Jee HeeJung,
Cha Sung Ho,
Chang Gyu Tae
Publication year - 2018
Publication title -
phytotherapy research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.019
H-Index - 129
eISSN - 1099-1573
pISSN - 0951-418X
DOI - 10.1002/ptr.5886
Subject(s) - percentile , medicine , placebo , mean difference , randomized controlled trial , short stature , significant difference , bone age , confidence interval , mathematics , statistics , alternative medicine , pathology
HT042 is a standardized functional food ingredient approved by Korean Food and Drug Administration with a claim ‘HT042 can help height growth of children’. We aimed to evaluate the safety and efficacy of HT042 on height growth in children with mild short stature. A multicenter, randomized, double‐blind, placebo‐controlled parallel study was performed on children aged 6–8 years with height ranked below the 25th percentile. In 129 children, height gain was significantly higher in HT042 group than placebo group after 24 weeks (mean difference, 0.29 cm; 95% CI, 0.01 to 0.57 cm; p = 0.027). The difference was elevated when the efficacy analysis was restricted to children below the 10th percentile (mean difference, 0.45 cm; 95% CI, 0.04 to 0.87 cm; p = 0.031). Because bone age advancement was lower in HT042 group, height standard deviation score gain for bone age was higher in HT042 group and the difference was significant in children below the 10th percentile (mean difference, 0.20 score; 95% CI, 0.00 to 0.39 points; p = 0.045). Serum IGF‐1 and IGFBP‐3 levels were significantly increased compared with baseline within HT042 group, but group difference was not significant. HT042 supplementation helped to increase height growth in children without skeletal maturation and was more effective in much shorter children. The effects might be mediated by increases in serum IGF‐1 and IGFBP‐3 levels. Copyright © 2017 John Wiley & Sons, Ltd.