This study is a double-blind randomized clinical trial (RCT). The aim of this study is to evaluate the effect of zinc supplement on the level of general health of ICU nurses. 46 patients, who qualified for study entry, randomly allocate in two equal groups. Inclusion criteria are: Low serum zinc level; Full-time nurses with a bachelor's degree or higher; Minimum of one year experience in ICU. Exclusion criteria are: Unwillingness to continue the study; History of diabetes, psychiatric, gastrointestinal, autoimmune, rheumatic disease; Micronutrients and supplements usage; Cigarette Smoking. Intervention group receive one Zinc sulfate 220 mg capsule per 72 hour for one month and control group receive one placebo capsule per 72 hour for one month. Before and at the end of the trial general health questionnaire will be completed by nurses and for measuring of serum Zinc, cooper and CBC, five milliliter blood will be sampled from antecubital vein. After collecting and classifying of information, data will be analyzed with SPSS18.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206254365N13
Registration date:2012-07-15, 1391/04/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-15, 1391/04/25
Registrant information
Name
Afshin Gholipour Baradari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 1245
Email address
gholipourafshin@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mazandaran University of Medical Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of zinc supplement on the level of general health of ICU nurses
Public title
Effect of zinc supplement on the level of general health of ICU nurses
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Low serum zinc level; Full-time nurses with a bachelor's degree or higher; Minimum of one year experience in ICU
Exclusion criteria: Unwillingness to continue the study; History of diabetes, psychiatric, gastrointestinal, autoimmune, rheumatic disease; Micronutrients and supplements usage; Cigarette Smoking
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
update
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
sari
Postal code
46175866
Approval date
2012-02-22, 1390/12/03
Ethics committee reference number
H-90-40
Health conditions studied
1
Description of health condition studied
Dietary zinc deficiency
ICD-10 code
E60
ICD-10 code description
Dietary zinc deficiency
Primary outcomes
1
Description
general health
Timepoint
before intervention and one months
Method of measurement
general health questionnaire
Secondary outcomes
1
Description
serum zinc level
Timepoint
before trial,one months later
Method of measurement
Laboratory kit
Intervention groups
1
Description
Intervention group, Cap Zinc sulfate 220 mg/72 h for one month
Category
Treatment - Drugs
2
Description
Control group, placebo/72h for one month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini General Hospital
Full name of responsible person
Afshin Gholipour Baradari, MD
Street address
Imam Khomeini general Hospital, Amir St, Sari, Iran
City
sari
2
Recruitment center
Name of recruitment center
Mazandaran heart center
Full name of responsible person
Afshin Gholipour Baradari, MD
Street address
Mazandaran Heart center, Artesh Blvd, Sari, Iran
City
sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmad Ali Enayati
Street address
Mazandaran university of medical sciences, Moallem Square, Sari, Iran Sari Mazandaran Iran, Islamic Republic Of 48175-866 00981513262679 00 00981513262679 medjournal@mazums.ac.ir www.mazums.ac.ir
City
sari
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 of Mazandaran 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
Mazandaran University Of Medical Sciences
Full name of responsible person
Afshin Gholipour Baradari, MD
Position
CCMF, Assistant Professor, Chief of ICU
Other areas of specialty/work
Street address
Moallem Square, Mazandaran University of Medical Sciences
City
Sari
Postal code
48175-866
Phone
+98 15 1326 2679
Fax
+98 15 1326 2679
Email
gholipourafshin@yahoo.com
Web page address
www.mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Afshin Gholipour Baradari, MD
Position
CCMF, Assistant Professor, Chief of ICU
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Moallem Square, Sari, Iran