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IRCT20200301046655N1 IRCT 2020-03-14 Shahid Beheshti University of Medical Sciences The effect of protein supplement on paraspinal muscles in spine surgery The effect of protein supplement on paraspinal muscles in patients undergoing lumbar posterior spine fusion surgery 2020-04-08 anticipated 60 Complete https://irct.ir/trial/46245 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization, Random number table, Blinding description: The patient, researcher, surgeon, nurse, and study analyzer will be blind to the intervention (protein supplement) and control (maltodextrin) groups. The supplements (protein and maltodextrin) are made by the manufacturer (Karen Iran) in a very similar packaging and only the code in each package specifies which protein and maltodextrin that will inform our company at the end of the study. 3 patients undergoing lumbar posterior spine fusion surgery. Intervention 1: Intervention group: 3 Sachet Pure protein (15 g per sachet contains 12.6 grams of protein, 1 g carbohydrates, 0.4 g fat, 58 calories, Karen Iran) after surgery up to a month after surgery. Intervention 2: Control group: protein diet (1.2 g/kg/day) and maltodextrin for 1 month after surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I haven't decided yet - its release schedule is still unclear.
public Razieh Khalooeifard
Tajrish Martyrs Hospital, Tajrish Square
Tehran Iran (Islamic Republic of) 198887335 +98 21 2274 9201 shkhalooei1367@gmail.com Shahid Beheshti University of Medical Sciences scientific saeed oraee yazdani
Tajrish Martyrs Hospital, Tajrish Square
Tehran Iran (Islamic Republic of) 198887335 +98 21 2274 9201 saeed_o_yazdani@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Candidate for Posterior Lumbar Spine Fusion Elective Surgery 18 years 65 years Both Severe liver disorder Severe renal disorder Osteoporosis (T score ≤ 2.5) Spinal trauma and fracture Diabetes Gastrointestinal malabsorption Parathyroid gland disorders Any neuromuscular disease such as dystrophies and neurological disorders smoking Use of drugs that affect bone metabolism, such as calcitonin, bisphosphonate, corticosteroids M51.17 Intervertebral disc disorders with myelopathy, lumbar region Treatment - Surgery Treatment - Surgery Intervention group: 3 Sachet Pure protein (15 g per sachet contains 12.6 grams of protein, 1 g carbohydrates, 0.4 g fat, 58 calories, Karen Iran) after surgery up to a month after surgery Control group: protein diet (1.2 g/kg/day) and maltodextrin for 1 month after surgery. Paraspinal Muscle Thickness. Timepoint: Baseline and 3 months after surgery. Method of measurement: computed tomography scan. NCT04300517 ClinicalTrials.gov Shahid Beheshti University of Medical Sciences Approved 2020-02-16 Ethics committee of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Scie Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran Tehran Iran (Islamic Republic of)