Diabetes is common in Yazd city and Zinc deficiency is expected to be high as Zinc is a rare element and not in abundance in this city. Zinc has an essential role in insulin function. The aim of this study was to evaluate the effect of zinc supplement in HbA1c in a group of type-II diabetic patients. Methods: In this clinical trial study, 60 patients were chosen. Half of them received 25 mg Zinc Sulfate per day for 8 weeks and half of them received 50 mg Zinc supplementation daily for 8 weeks. Serum level of zinc, FBS, 2hpp , HbA1c were evaluated in patient before and after intervention. Inclusion criteria: Age:40-60, HbA1c greater7 ,TG Lesser than 400 mg/dl, Cho Lesser than 250 mg/dl. Exclusion Criteria: Smoking, using antioxidant drug, using insulin and renal disease.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812212676N2
Registration date:2010-06-19, 1389/03/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-19, 1389/03/29
Registrant information
Name
Robab Sheikhpour
Name of organization / entity
Azad University
Country
Iran (Islamic Republic of)
Phone
+98 35 1623 5958
Email address
info@jauashkezar.ac.ir
Recruitment status
Recruitment complete
Funding source
Diabetes center of Yazd
Expected recruitment start date
2008-04-20, 1387/02/01
Expected recruitment end date
2008-06-21, 1387/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaulation of the effect of zinc supplement on control status of diabetes in diabetic patients
Public title
The effect of zinc supplement on control status of diabetes in diabetic Patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Age 40-60, HbA1c greater than 7, TG Less than 400 mg/dl, Cho Less than 250 mg/dl .
Exclusion criteria: Smoking, using antioxidant drug, using insulin and renal disease
Age
From 40 years old to 61 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadouqi University of Medical Sciences
Street address
Central administration office, Bahonar square
City
Yazd city
Postal code
Approval date
2009-07-11, 1388/04/20
Ethics committee reference number
p/1/17/3944
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10, E11,
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
HbA1C
Timepoint
1 Month prior to intervention, 2 Month after intervention
Method of measurement
Cell counter instrument
Secondary outcomes
1
Description
Fasting blood sugar and 2 hours postprandial
Timepoint
1 Month prior to intervention, 2 Month after intervention
Method of measurement
Photometer instrument
2
Description
Serum Zinc level
Timepoint
1 Month prior to intervention, 2 Month after intervention
Method of measurement
ELIZA
Intervention groups
1
Description
Zinc sulphate, 50 Mg oral capsule, One capsule every other day for 2 month
Category
Treatment - Drugs
2
Description
Zinc sulphate, 50 Mg oral capsule, One capsule every day for 2 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes center of Yazd
Full name of responsible person
Dr Mohammad Afkhami, Associate professor
Street address
Diabetes center, Next to Afshar hospital, Jomhouri avenue
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Diabetes center of Yazd
Full name of responsible person
Dr Mohammad Afkhami, Associate Professor
Street address
Diabetes center of Yazd, Next to Afshar hospital, Jomhouri avenue
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Diabetes center of Yazd
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
Azad University
Full name of responsible person
Robab Sheikhpour
Position
MSc, Academic member
Other areas of specialty/work
Street address
Azad University, Charkhab avenue,
City
Ashkezar
Postal code
00983518915656965
Phone
+98 35 1623 5958
Fax
Email
Sheikhpour_r@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Azad University
Full name of responsible person
Robab Sheikhpour
Position
MSc, Academic member
Other areas of specialty/work
Street address
Azad University, Charkhab avenue,
City
Ashkezar
Postal code
00983518915656965
Phone
+98 35 1623 5958
Fax
Email
sheikhpour_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Azad university
Full name of responsible person
Robab Sheikhpour
Position
MSc Academic member
Other areas of specialty/work
Street address
Azad university, Charkhab avenue,
City
Ashkezar
Postal code
00983518915656965
Phone
+98 35 1623 5958
Fax
+98 35 1628 2884
Email
Sheikhpour_r@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)