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

NCT ID: NCT04091841

Last Updated: 2020-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spine Surgery

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Study Groups

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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.

Group Type EXPERIMENTAL

protein supplement

Intervention Type DRUG

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

Carbo Mass

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

Group Type PLACEBO_COMPARATOR

Carbo Mass

Intervention Type OTHER

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

Interventions

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protein supplement

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

Intervention Type DRUG

Carbo Mass

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

Intervention Type OTHER

Other Intervention Names

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Pure-protein

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University

OTHER

Sponsor Role lead

Responsible Party

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Zahra Vahdat Shariatpanahi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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zahra vahdat shariatpanahi, MD,PhD

Role: STUDY_CHAIR

Faculty of Nutrition and Food Technology, SBMU

Locations

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Zahra vahdat shariatpanahi

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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1398/022

Identifier Type: -

Identifier Source: org_study_id