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Trial record 18 of 497 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

Tracking Information
First Submitted Date  ICMJE August 5, 2019
First Posted Date  ICMJE September 17, 2019
Last Update Posted Date September 17, 2019
Actual Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2019)
Rate of vertebral fusion in CT scan [ Time Frame: 3 months after surgery ]
Rate of formation of a solid bony Union in CT scan
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2019)
  • 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.
  • Rate of of wound infection [ Time Frame: 48 hour and 10 days after surgery ]
    Rate of of wound infection, revealed by physical examination
  • 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
  • Concentration of serum IGF-1 [ Time Frame: baseline, 1 month after surgery ]
    Concentration of Insulin-like growth factor-1
  • Concentration of serum albumin [ Time Frame: baseline, 1 month after surgery ]
    Concentration of serum albumin
  • Concentration of serum total protein [ Time Frame: baseline, 1 month after surgery ]
    Concentration of serum total protein
  • Concentration of serum hsCRP [ Time Frame: baseline, 10 days after the surgery ]
    Concentration of serum high-sensitivity C-reactive protein
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Protein Supplement on Vertebral Fusion in Posterior Spine Fusion Surgery
Official Title  ICMJE The Effect of Protein Supplement on Vertebral Fusion and Enhanced Recovery After Posterior Spine Fusion Surgery
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Spine Surgery
Intervention  ICMJE
  • Drug: protein supplement
    Three sachet of protein supplement to be mixed in with water used daily.
    Other Name: Pure-protein
  • Other: Maltodextrine
    Three sachet of Maltodextrine supplement to be mixed in with water used daily.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: protein supplement
  • Placebo Comparator: maltodextrin
    Control patients will be received protein diet (1.2 g/kg/day) and maltodextrin for 1 month after surgery.
    Intervention: Other: Maltodextrine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 14, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04091841
Other Study ID Numbers  ICMJE 1398/022
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zahra Vahdat Shariatpanahi, Shahid Beheshti University
Study Sponsor  ICMJE Shahid Beheshti University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: zahra vahdat shariatpanahi, MD,PhD Faculty of Nutrition and Food Technology, SBMU
PRS Account Shahid Beheshti University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP