This double-blind, randomized clinical trial has been done to determine the effects of zinc supplementation on clinical outcomes of patients with severe head trauma. The study was carried out in ICU of Shahid kamyab hospital of Mashhad. One hundred patients with severe head trauma, aged between 18 to 65 years and Glasgow outcome score (GSC) of 6 to 8 randomly allocated to either supplementation and placebo group. The groups receive 120 mg zinc (528 mg zinc sulfate) or placebo through enteral feeding for 15 days, respectively. Plasma zinc and copper, 24-hour urine zinc concentrations, plasma albumin, Sequential Organ Failure Assessment (SOFA), and GCS were assessed on day one, seven and sixteen. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), and White Blood Cell (WBC) count were measured on day one and sixteen. GCS and mortality rate were assessed on 28th day. The length of hospital stay and Glasgow Outcome Score (GOS) were calculated on hospital discharge day. All patients received enteral or parenteral feeding and gastric intolerance, amount of energy and protein were assessed during the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016053028176N1
Registration date:2016-06-23, 1395/04/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-23, 1395/04/03
Registrant information
Name
Maryam Khazdouz
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 8888
Email address
moshen@genetics.ac.cn
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of zinc supplementation and plasebo on clinical improvement of severe head trauma patients admitted to ICU: A Randomized Clinical Trial
Public title
Effect of zinc supplementation on severe head trauma patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Severe head trauma patients; aged between 18 to 65 years; GCS between 6-8
Exclusion criteria: patients undergoing a craniotomy; or with a medical history of liver, respiratory or renal disease; diabetes; hypertension and cardiovascular diseases; blood clotting problems; cancer and ongoing pregnancy; patients whit contraindication of enteral nutrition
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
method of randomly allocation of the study is using random number tables
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Administration Center(Qoreishi Building) – Daneshgah St
City
Mashhad
Postal code
Approval date
2012-07-22, 1391/05/01
Ethics committee reference number
910055
Health conditions studied
1
Description of health condition studied
severe head trauma
ICD-10 code
(S00-S09)
ICD-10 code description
Injuries to the head
Primary outcomes
1
Description
Glasgow outcome score (GCS)
Timepoint
First 24 hours of admission, 7th, 16th and 28th day
Method of measurement
GCS table
2
Description
Sequential Organ Failure Assessment (SOFA)
Timepoint
First 24 h of admission, 7th and 16 th day
Method of measurement
SOFA table
3
Description
Zinc plasma concentrations
Timepoint
First 24 hours of admission, 7th and 16th day
Method of measurement
Atomic absorption spectrophotometer
4
Description
C-reactive protein (CRP)
Timepoint
First 24 hours of admission and 16th day
Method of measurement
CRP ELISA Kit
Secondary outcomes
1
Description
Copper plasma concentrations
Timepoint
first 24 hours of admission, 7th and 16th day
Method of measurement
Atomic absorption spectrophotometer
2
Description
length of hospital stay (LOS)
Timepoint
at discharge day
Method of measurement
number of hospitalization days
3
Description
Glasgow Outcome Score (GOS)
Timepoint
At hospital discharge day
Method of measurement
GOS table
4
Description
Erythrocyte sedimentation rate (ESR)
Timepoint
First 24 hours of admission and 16th day
Method of measurement
Centrifuged
5
Description
white blood cell (WBC) count
Timepoint
First 24 hours of admission and 16th day
Method of measurement
Conunt of WBC with cell counter
6
Description
Mortality rate
Timepoint
At hospital discharge day
Method of measurement
Conunt of patients (dead and alive)
7
Description
Enteral intake and parenteral administered
Timepoint
Daily
Method of measurement
Recods of amounts of intake
Intervention groups
1
Description
Intervention: 120 mg zinc elemental (528 mg zinc sulfat) as 20 ml zinc solution that were prepared by the study pharmacist in the Investigative Pharmacy Research Centre affiliated to Mashhad University of Medical Sciences Number of use: 2 times per day (10 ml at any time) for 15 days
Category
Treatment - Drugs
2
Description
Control: 20 ml distilled water that were prepared by the study pharmacist in the Investigative Pharmacy Research Centre affiliated to Mashhad University of Medical Sciences Number of use: 2 times per day (10 ml at any time) for 15 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Kamyab Hospital in Mashhad
Full name of responsible person
Dr Mohamadeza Ehsaii
Street address
Fadaieyan Eslam Avenue, Nakhrisi Square
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen tafaghodi
Street address
Administration Center(Qoreishi Building) – Daneshgah St
City
Mashhad
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Medicine, Mashhad University of Medical Sciences
Full name of responsible person
Mohamad safarian
Position
Associate Professor of Nutrition Sciences
Other areas of specialty/work
Street address
Pardis ّAlley, Azadi Square
City
Mashhad
Postal code
917794-8564
Phone
+98 51 3882 8888
Fax
Email
safarianM@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam khazdouz
Position
Msc of nutrition
Other areas of specialty/work
Street address
Shahid Hemmat Highway
City
Tehran
Postal code
1449614535
Phone
+98 45 3325 0610
Fax
Email
maryam.khazdouz@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Maryam khazdouz
Position
PHD Student of nutrition
Other areas of specialty/work
Street address
Shahid Hemmat Highway
City
Tehran
Postal code
1449614535
Phone
+98 45 3325 0610
Fax
Email
Maryam.khazdouz@hotmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)