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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT2014122014901N5 |
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Date of registration:
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2014-12-31 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Beta-glucan and trauma
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Scientific title:
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Effect of Beta-glucan on serum level of IL-12, hs-CRP and clinical outcomes in Multiple trauma patients: a prospective randomized pilot study |
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Date of first enrolment:
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2013-05-22 |
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Target sample size:
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40 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/14363 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.
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Phase:
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N/A
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Zahra Vahdat Shariatpanahi
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Address:
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3, Baran, West Arghavan, Farahzadi Blvd., Shahrak Qods,
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21223574834 |
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Email:
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nutritiondata@yahoo.com z.shariatpanahi@sbmu.ac.ir |
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Affiliation:
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Faculty of Nutrition and Food Sciences, Shahid Beheshti University of Medical Sciences |
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Name:
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Zahra Vahdat Shariatpanahi
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Address:
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3, Baran, West Arghavan, Farahzadi Blvd., Shahrak Qods,Tehran, I.R. Iran
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21223574843 |
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Email:
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nutritiondata@yahoo.com |
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Affiliation:
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Faculty of Nutrition and Food Sciences, Shahid Beheshti University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria: age older than 18 years; having two or more organ-system traumas, with the prediction of a life expectancy more than 21 days after randomization; need to be mechanically ventilated. no previous digestive, diabetes, respiratory or infectious diseases; no pregnancy; no lactation; no immunosuppression; no obesity (body mass index > 30) nor malnutrition (body mass index < 18.5); no any contraindication to enteral administration Exclusion criteria: Discharge or death before 10 days
Exclusion criteria:
Age minimum:
18 years
Age maximum:
80 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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trauma.
Unspecified early complication of trauma
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Unspecified early complication of trauma
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Intervention(s)
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control: high protein diet plus carbomass
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Prevention
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Intervention 1: study: high protein diet plus 3 grams beta-glucan. Intervention 2: control: high protein diet plus carbomass.
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study: high protein diet plus 3 grams beta-glucan
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Primary Outcome(s)
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Interlukin-12. Timepoint: day 1, day 21. Method of measurement: ELISA.
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Secondary Outcome(s)
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Infection incidense. Timepoint: daily. Method of measurement: Clinical and Paraclinical.
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Organ failure. Timepoint: daily. Method of measurement: Clinical and Paraclinical.
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Lenght of ICU stay. Timepoint: daily. Method of measurement: observation.
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Lenght of ventilation. Timepoint: daily. Method of measurement: observation.
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Source(s) of Monetary Support
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National Nutrition and Food Technology Research Institute
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Ethics review
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Status: Approved
Approval date:
Contact:
Faculty of Nutrition and Food Sciencees, Shahid Beheshti University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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