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

NCT04091841 | Completed DMC

• 1 other identifier: 1398/022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Spine Surgery

Keywords

Protein supplement; Protein diet; Vertebral fusion; Enhanced recovery after surgery; Infection; Wound healing; Pain

Outcome Measures

Primary Outcomes (1)

• Rate of vertebral fusion in CT scan

  Rate of formation of a solid bony Union in CT scan

  6 months after surgery

Secondary Outcomes (7)

• Rate of wound healing

  Discharge, 15 days and 1 month after surgery

• Rate of of wound infection

  15 days, 1 and 3 month after surgery

• score of pre and postoperative pain

  baseline, discharge, 15 days 1 and 3 month after surgery

• Concentration of serum IGF-1

  baseline, 1 month after surgery

• Concentration of serum albumin

  baseline, 1 month after surgery

Study Arms (2)

protein supplement

EXPERIMENTAL

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

Drug: protein supplement

Carbo Mass

PLACEBO COMPARATOR

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

Other: Carbo Mass

Interventions

protein supplement DRUG

Three sachet of protein supplement to be mixed in with water used daily.

Also known as: Pure-protein

protein supplement

Carbo Mass OTHER

Three sachet of Carbo Mass supplement to be mixed in with water used daily.

Carbo Mass

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Allergy or intolerance to protein or maltodextrine supplement
• Unwillingness to continue cooperation

Sponsors & Collaborators

• Shahid Beheshti University: lead

Study Sites (1)

Zahra vahdat shariatpanahi

Tehran, +98, Iran

Location

MeSH Terms

Conditions

Infections; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• zahra vahdat shariatpanahi, MD,PhD

  Faculty of Nutrition and Food Technology, SBMU

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: September 17, 2019
• Study Start: August 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

IR (1)