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http://dx.doi.org/10.7778/jpkm.2019.33.4.37

Randomized, Double-blind, and Placebo-controlled a Human Study for Growing of Stature via the Analysis of Effect of Ferment Oyster Extract: Study Protocol  

Kim, Hee-Yeon (Department of Korean Pediatrics, Pusan National University Korean Medicine Hospital)
Park, Beom-Chan (Department of Korean Pediatrics, Pusan National University Korean Medicine Hospital)
Cheon, Jin-Hong (Department of Korean Pediatrics, Pusan National University Korean Medicine Hospital)
Choi, Jun-Yong (Department of Korean Internal Medicine, Pusan National University Korean Medicine Hospital)
An, Byeong-Min (General Biotech)
Park, Joung-Hyun (Marine Bioprocess Co. Ltd.)
Lee, Bae-Jin (Marine Bioprocess Co. Ltd.)
Kim, Kibong (Department of Korean Pediatrics, Pusan National University Korean Medicine Hospital)
Publication Information
The Journal of Pediatrics of Korean Medicine / v.33, no.4, 2019 , pp. 37-46 More about this Journal
Abstract
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.
Keywords
Ferment oyster extract; Short stature; Growth; Human study; Protocol;
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