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Trial record 18 of 496 for:    Supplement | maltodextrin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04091841
Recruitment Status : Active, not recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Zahra Vahdat Shariatpanahi, Shahid Beheshti University

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.

Condition or disease Intervention/treatment Phase
Spine Surgery Drug: protein supplement Other: Maltodextrine Phase 3

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 criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 60 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 maltodextrin 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Protein Supplement on Vertebral Fusion and Enhanced Recovery After Posterior Spine Fusion Surgery
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: protein supplement
Three sachet of protein supplement to be mixed in with water used daily.
Other Name: Pure-protein

Placebo Comparator: maltodextrin
Control patients will be received protein diet (1.2 g/kg/day) and maltodextrin for 1 month after surgery.
Other: Maltodextrine
Three sachet of Maltodextrine supplement to be mixed in with water used daily.




Primary Outcome Measures :
  1. Rate of vertebral fusion in CT scan [ Time Frame: 3 months after surgery ]
    Rate of formation of a solid bony Union in CT scan


Secondary Outcome Measures :
  1. Rate of wound healing [ Time Frame: 48 hour, 10 days and 1 month after surgery ]
    Rate of wound healing, the sutures of the surgery, inspected by granulation tissue formation.

  2. Rate of of wound infection [ Time Frame: 48 hour and 10 days after surgery ]
    Rate of of wound infection, revealed by physical examination

  3. score of pre and postoperative pain [ Time Frame: baseline, 48 hour, 10 days 1 and 3 month after surgery ]
    pain measured by the visual analogue scale or visual analog scale (VAS) questionnaire

  4. Concentration of serum IGF-1 [ Time Frame: baseline, 1 month after surgery ]
    Concentration of Insulin-like growth factor-1

  5. Concentration of serum albumin [ Time Frame: baseline, 1 month after surgery ]
    Concentration of serum albumin

  6. Concentration of serum total protein [ Time Frame: baseline, 1 month after surgery ]
    Concentration of serum total protein

  7. Concentration of serum hsCRP [ Time Frame: baseline, 10 days after the surgery ]
    Concentration of serum high-sensitivity C-reactive protein



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091841


Locations
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Iran, Islamic Republic of
Zahra vahdat shariatpanahi
Tehran, Iran, Islamic Republic of, +98
Sponsors and Collaborators
Shahid Beheshti University
Investigators
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Study Chair: zahra vahdat shariatpanahi, MD,PhD Faculty of Nutrition and Food Technology, SBMU

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Responsible Party: Zahra Vahdat Shariatpanahi, Principal Investigator, Shahid Beheshti University
ClinicalTrials.gov Identifier: NCT04091841    
Other Study ID Numbers: 1398/022
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zahra Vahdat Shariatpanahi, Shahid Beheshti University:
Protein supplement
Protein diet
Vertebral fusion
Enhanced recovery after surgery
Infection
Wound healing
Pain