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Effect of Protein Supplement on Paraspinal Muscles in Spine Surgery

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ClinicalTrials.gov Identifier: NCT04300517
Recruitment Status : Completed
First Posted : March 9, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Zahra Vahdat Shariatpanahi, Shahid Beheshti University

Tracking Information
First Submitted Date  ICMJE March 3, 2020
First Posted Date  ICMJE March 9, 2020
Last Update Posted Date July 28, 2020
Actual Study Start Date  ICMJE February 1, 2020
Actual Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2020)
The thickness of the paraspinal muscles in CT scan [ Time Frame: 3 months after surgery ]
The thickness of the paraspinal muscles (multifidus, erector spinae, Quadratus, and Lumborum) in CT scan
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2020)
Degree and severity of paraspinal muscle mass atrophy in CT scan [ Time Frame: baseline, and 3 months after surgery ]
Degree and severity of paraspinal muscle mass atrophy (multifidus, erector spinae, Quadratus, and Lumborum) in CT scan
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Protein Supplement on Paraspinal Muscles in Spine Surgery
Official Title  ICMJE The Effect of Protein Supplement on Paraspinal Muscles in Patients Undergoing Lumbar Posterior Spine Fusion Surgery
Brief Summary

Protein intake in spinal fusion surgery can prevent paraspinal muscle atrophy by maintaining muscle mass, regeneration, and growth. Also, by reducing the amount of pseudarthrosis, pain and disability can have a positive effect on recovery.

The high prevalence of this type of surgery, the instability and degeneration of adjacent surfaces of fused sections, lumbar muscle atrophy, increased muscle tissue fat, and negative impact on patient recovery, also with regard to the fact that research has so far aimed to determine The effect of protein supplementation on para-spinal muscles has not been studied in patients undergoing posterior lumbar spine fusion surgery, therefore clinical trials are necessary. In this trial patients undergoing elective posterior spine fusion surgery are divided into two groups of intervention or control.

Detailed Description A randomized, double blind, controlled trial will be conducted in patients undergoing elective posterior spine fusion surgery in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 80 eligible posterior spine fusion surgery patients, aged ≥ 18 years. Intervention patients will be received 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 be received 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Spine Surgery
Intervention  ICMJE Drug: Three sachet of protein supplement to be mixed in with water used daily
Three sachet of protein supplement to be mixed in with water used daily
Other Name: Pure-protein®
Study Arms  ICMJE
  • Experimental: protein supplement
    Intervention patients will be received protein diet (1.2 g/kg/day) and protein supplement (36 g/day) for 1 month after surgery.
    Intervention: Drug: Three sachet of protein supplement to be mixed in with water used daily
  • Placebo Comparator: maltodextrin
    Control patients will be received protein diet (1.2 g/kg/day) and maltodextrin for 1 month after surgery.
    Intervention: Drug: Three sachet of protein supplement to be mixed in with water used daily
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2020)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 1, 2020
Actual Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients 18-65 years
  • Body mass index 18.5-30
  • Candidate for the elective posterior spine fusion
  • Without history of severe liver disorder
  • Without history of Kidney disorder
  • Without history of diabetes
  • Without history of trauma and fracture of the vertebral
  • Without history of osteoporosis
  • Without history of Gastrointestinal malabsorption
  • Without history of Parathyroid gland disorders
  • Without taking medications that affect the metabolism of bone, such as calcitonin, bisphosphonate, corticosteroid
  • No smoking
  • Without history of neuromuscular diseases such as dystrophies and neurological disorders

Exclusion Criteria:

  • Allergy or intolerance to protein or maltodextrine supplement
  • Unwillingness to continue cooperation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04300517
Other Study ID Numbers  ICMJE 1398/802
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zahra Vahdat Shariatpanahi, Shahid Beheshti University
Study Sponsor  ICMJE Shahid Beheshti University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shahid Beheshti University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP