Status:
COMPLETED
Effect of Protein Supplement on Paraspinal Muscles in Spine Surgery
Lead Sponsor:
Shahid Beheshti University
Conditions:
Spine Surgery
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
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 criter...
Eligibility Criteria
Inclusion
- 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
- Allergy or intolerance to protein or maltodextrine supplement
- Unwillingness to continue cooperation
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04300517
Start Date
February 1 2020
End Date
July 1 2020
Last Update
July 28 2020
Active Locations (1)
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1
Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Shohada Tajrish Hospital
Tehran, Iran