Overall purpose
Effect of Protein Supplementation on Para Spinal Muscles in Lumbar Spine Posterior Fusion Surgery
Specific goals
1. Evaluation and Comparison of Thickness of Paraspinal Muscle with CT Scan
2. Evaluation and comparison of degree and severity of paraspinal muscle mass atrophy with CT scan
Design
A randomized, controlled, double-blind, placebo-controlled clinical trial
Settings and conduct
Intervention patients will receive 36 grams of protein supplement along with diet containing 1.2 g/kg/day of protein for 30 days after surgery and control patients will receive maltodextrin along with diet containing 1.2 g/kg/day of protein 30 days after surgery. Patients will be evaluated for occurrence of paraspinal muscles after 3 months surgery.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Adult patients 18-65 years;Body mass index 18.5-30;Candidate for the elective posterior spine fusion.
Exclusion Criteria:
history of severe liver disorder; history of Kidney disorder;history of diabetes; smoking;Without history of neuromuscular diseases such as dystrophies and neurological disorders.
Intervention groups
Intervention:
protein diet (1.2 g/kg/day) and protein supplement (36 g/day) for 1 month after surgery.
Placebo :
protein diet (1.2 g/kg/day) and maltodextrin for 1 month after surgery.
Main outcome variables
The thickness of the paraspinal muscles (multifidus, erector spinae, Quadratus, and Lumborum) in CT scan
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200301046655N1
Registration date:2020-03-14, 1398/12/24
Registration timing:prospective
Last update:2020-03-14, 1398/12/24
Update count:0
Registration date
2020-03-14, 1398/12/24
Registrant information
Name
Razieh Khalooeifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
shkhalooei1367@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-08, 1399/01/20
Expected recruitment end date
2020-06-09, 1399/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of protein supplement on paraspinal muscles in patients undergoing lumbar posterior spine fusion surgery
Public title
The effect of protein supplement on paraspinal muscles in spine surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Candidate for Posterior Lumbar Spine Fusion Elective Surgery
Exclusion criteria:
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, Random number table
Blinding (investigator's opinion)
Triple blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
ClinicalTrials.gov
Secondary trial Id
NCT04300517
Registration date
2020-03-05, 1398/12/15
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Scie
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town,
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-02-16, 1398/11/27
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.802
Health conditions studied
1
Description of health condition studied
patients undergoing lumbar posterior spine fusion surgery
ICD-10 code
M51.17
ICD-10 code description
Intervertebral disc disorders with myelopathy, lumbar region
Primary outcomes
1
Description
Paraspinal Muscle Thickness
Timepoint
Baseline and 3 months after surgery
Method of measurement
computed tomography scan
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Treatment - Surgery
2
Description
Control group: protein diet (1.2 g/kg/day) and maltodextrin for 1 month after surgery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish hospital
Full name of responsible person
Dr Saeed Oraee Yazdani
Street address
Tajrish Sq
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9982
Email
Intl_office@sbmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice-Chancellor in Research Affairs
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town,
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8145 5618
Email
ethics@behdasht.gov.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Razieh Khalooeifard
Position
student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Tajrish Martyrs Hospital, Tajrish Square
City
Tehran
Province
Tehran
Postal code
198887335
Phone
+98 21 2274 9201
Email
shkhalooei1367@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
saeed oraee yazdani
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Tajrish Martyrs Hospital, Tajrish Square
City
Tehran
Province
Tehran
Postal code
198887335
Phone
+98 21 2274 9201
Email
saeed_o_yazdani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Razieh Khalooeifard
Position
student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Tajrish Martyrs Hospital, Tajrish Square
City
Tehran
Province
Tehran
Postal code
198887335
Phone
+98 21 2274 9201
Email
shkhalooei1367@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available