Trial of Protein Supplement on Vertebral Fusion in Posterior Spine Fusion Surgery

Shahid Beheshti University

Status: Completed

Conditions: Spine Surgery

Treatments: Other: Carbo Mass; Drug: protein supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT04091841

1398/022

Details and patient eligibility

About

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 phosphorous, and improving muscle strength.Therefore, protein may be effective on vertebral fusion by such mechanisms. In this trial patients undergoing elective posterior spine fusion surgery are divided into two groups of intervention or control.

Full 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 Carbo Mass along with diet containing 1.2 g/kg/day of protein 30 days after surgery. Patients will be evaluated for occurrence of vertebral fusion and enhanced recovery after 3 months surgery.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

protein supplement

Experimental group

Description:

Intervention patients will be received protein diet (1.2 g/kg/day) and protein supplement (36 g/day) for 1 month after surgery.

Treatment:

Drug: protein supplement

Carbo Mass

Placebo Comparator group

Description:

Control patients will be received protein diet (1.2 g/kg/day) and Carbo Mass for 1 month after surgery.

Treatment:

Other: Carbo Mass