Status:
COMPLETED
Trial of Protein Supplement on Vertebral Fusion in Posterior Spine Fusion Surgery
Lead Sponsor:
Shahid Beheshti University
Conditions:
Spine Surgery
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Receiving protein can affect the bone formation and maintenance by providing a structural matrix of the bone, optimizing the level of IGF-1, increasing intestinal calcium absorption, transferring phos...
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
- 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
- serum level of vitamin 25 (OH) D ≤20 ng/l
- Exclusion Criteria:
- Allergy or intolerance to protein or maltodextrine supplement
- Unwillingness to continue cooperation
Exclusion
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04091841
Start Date
August 1 2019
End Date
October 1 2020
Last Update
November 30 2020
Active Locations (1)
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1
Zahra vahdat shariatpanahi
Tehran, Iran, +98