Tokyo, May 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061450) titled 'Postoperative Branched-Chain Amino Acid Supplementation Preserves Muscle Mass and Enhances Functional Recovery after Hip Fracture Surgery: A Randomized, Placebo-Controlled Trial' on May 4.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Yoshimoto Orthopaedic and Surgery Hospital
Condition:
Condition - Hip Fracture
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to investigate whether the administration of branched-chain amino acids (BCAAs) from the acute perioperative phase following proximal femoral fractures in frail elderly patients can lead to improvements in muscle recovery, nutritional status and functional outcomes.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Take 2g of BCAA after every meal
Interventions/Control_2 - Take 2 g of lactose after every meal
Eligibility:
Age-lower limit - 65
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients aged 65 and over who have undergone surgery for a proximal femoral fracture
Key exclusion criteria - Patients who were refused participation in the study, patients who were unable to undergo surgery
Target Size - 60
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2020 Year 05 Month 01 Day
Date of IRB - 2020 Year 05 Month 10 Day
Anticipated trial start date - 2020 Year 05 Month 27 Day
Last follow-up date - 2020 Year 11 Month 15 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070283
Disclaimer: Curated by HT Syndication.
