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KMID : 0363420190330040037
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Journal of Korean Oriental Pediatrics
2019 Volume.33 No. 4 p.37 ~ p.46
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Randomized, Double-blind, and Placebo-controlled a Human Study for Growing of Stature via the Analysis of Effect of Ferment Oyster Extract: Study Protocol
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Kim Hee-Yeon
Park Beom-Chan
Cheon Jin-Hong
Choi Jun-Yong
An Byeong-Min
Park Joung-Hyun
Lee Bae-Jin
Kim Ki-Bong
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Abstract
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Objectives: The purpose of this study is to confirm the efficacy and safety of the treatment of with fermented oyster extract on height growth in children with short stature.
Methods: A total of 100 people, between 6 and 11 years old, will be participated in a randomized, double-blind, and placebo-controlled human study. The fermented oyster group will take 500 mg of fermented oyster extract once a day for 24 weeks. The placebo group will take 3400 mg of fructooligosaccharide as placebo once a day for 24 weeks. The outcomes of the intervention will be measured at the baseline, 6 week, 12 week, 18 week, and 24 week. The primary outcome is the changes in height from the baseline. The secondary outcomes are growth rate, height SDS, bone age, GH, IGF-1, IGFBP-3, osteocalcin, BALP, DPD, and LH.
Results: This trial was approved by the institutional review board of Pusan National University Korean Medicine Hospital (registry number: PNUKHIRB-2019002). Recruitment of the research participants will be opened from May 2019 till December 2019.
Conclusions: This study will provide clinical information to determine the efficacy and safety of the treatment with fermented oyster extract on height growth in children with short stature
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KEYWORD
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Ferment oyster extract, Short stature, Growth, Human study, Protocol
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