Spine SurgeryNCT04091841
Trial of Protein Supplement on Vertebral Fusion in Posterior Spine Fusion Surgery
A study testing protein supplement and Carbo Mass in people with Spine Surgery, run by Shahid Beheshti University at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spine Surgery
- What is being tested?
- protein supplement and Carbo Mass
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- 1 Aug 2019to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- Allergy or intolerance to protein or maltodextrine supplement
- Unwillingness to continue cooperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Protein Supplement on Vertebral Fusion and Enhanced Recovery After Posterior Spine Fusion Surgery
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.
Read the 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 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
- Spine Surgery
- Being tested
- protein supplement, Carbo Mass
- Keywords
- Protein supplement, Protein diet, Vertebral fusion, Enhanced recovery after surgery, Infection, Wound healing, Pain
- Medical subject headings
- Infections, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein supplementDrug
Also called Pure-protein
Three sachet of protein supplement to be mixed in with water used daily.
Carbo MassOther
Three sachet of Carbo Mass supplement to be mixed in with water used daily.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Carbo Mass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of vertebral fusion in CT scan
Rate of formation of a solid bony Union in CT scan
Measured: 6 months after surgery
Secondary outcomes (7)
Rate of wound healing
Rate of wound healing, the sutures of the surgery, inspected by granulation tissue formation.
Measured: Discharge, 15 days and 1 month after surgery
Rate of of wound infection
Rate of of wound infection, revealed by physical examination
Measured: 15 days, 1 and 3 month after surgery
score of pre and postoperative pain
pain measured by the visual analogue scale or visual analog scale (VAS) questionnaire
Measured: baseline, discharge, 15 days 1 and 3 month after surgery
Concentration of serum IGF-1
Concentration of Insulin-like growth factor-1
Measured: baseline, 1 month after surgery
Concentration of serum albumin
Concentration of serum albumin
Measured: baseline, 1 month after surgery
Concentration of serum total protein
Concentration of serum total protein
Measured: baseline, 1 month after surgery
Concentration of serum hsCRP
Concentration of serum high-sensitivity C-reactive protein
Measured: baseline, 48 hour,15 days and 1 month after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start1 Aug 2019
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Vahdat Shariatpanahi, Shahid Beheshti University
- Investigators
- zahra vahdat shariatpanahi, MD,PhD, Study chair, Faculty of Nutrition and Food Technology, SBMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091841
- Sponsor's protocol ID
- 1398/022
- Status last verified
- Nov 2020
- First submitted
- 5 Aug 2019
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Protein Supplement on Vertebral Fusion and Enhanced Recovery After Posterior Spine Fusion Surgery
- ClinicalTrials.gov ID
- NCT04091841
- Acronym / sponsor ID
- 1398/022
- Conditions
- Spine Surgery
- Keywords
- Protein supplement, Protein diet, Vertebral fusion, Enhanced recovery after surgery, Infection, Wound healing, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| protein supplement | Experimental | Drug: protein supplementIntervention patients will be received protein diet (1.2 g/kg/day) and protein supplement (36 g/day) for 1 month after surgery. |
| Carbo Mass | Placebo comparator | Other: Carbo MassControl patients will be received protein diet (1.2 g/kg/day) and Carbo Mass for 1 month after surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (2 listed)
- Allergy or intolerance to protein or maltodextrine supplement
- Unwillingness to continue cooperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protein supplementAlso: Pure-proteinThree sachet of protein supplement to be mixed in with water used daily. | Drug | protein supplement |
| Carbo MassThree sachet of Carbo Mass supplement to be mixed in with water used daily. | Other | Carbo Mass |
Primary outcome
Rate of vertebral fusion in CT scan
Time frame: 6 months after surgery
Rate of formation of a solid bony Union in CT scan
7 secondary outcomes
Rate of wound healing
Time frame: Discharge, 15 days and 1 month after surgery
Rate of of wound infection
Time frame: 15 days, 1 and 3 month after surgery
score of pre and postoperative pain
Time frame: baseline, discharge, 15 days 1 and 3 month after surgery
Concentration of serum IGF-1
Time frame: baseline, 1 month after surgery
Concentration of serum albumin
Time frame: baseline, 1 month after surgery
Concentration of serum total protein
Time frame: baseline, 1 month after surgery
Concentration of serum hsCRP
Time frame: baseline, 48 hour,15 days and 1 month after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zahra vahdat shariatpanahi, MD,PhD study chair
Faculty of Nutrition and Food Technology, SBMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing protein supplement and Carbo Mass in people with Spine Surgery, run by Shahid Beheshti University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of vertebral fusion in CT scan (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.