Protocol summary

Summary
In this study the effect of zinc sulphate on HbA1C and serum zinc level in diabetic patient will be evaluated. 30 diabetic type 1 patient were included in this prospective and before-after study. The physician will use a checklist in the data collection; information on age, sex, duration of disease and HbA1C and serum zinc level of patient. Then one capsule of zinc sulphate (cotain 50 mg zinc element) will be added to participants regimen for 3 months. At the end of study HbA1C and serum zinc level will be rechecked. Finally HbA1C and serum zinc level changes will be evaluated

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138901303596N2
Registration date: 2010-11-16, 1389/08/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-11-16, 1389/08/25
Registrant information
Name
Elena Lak
Name of organization / entity
Ahvaz Jundishapur University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1337 9630
Email address
elenalak@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of medical sience.
Expected recruitment start date
2009-08-23, 1388/06/01
Expected recruitment end date
2010-03-11, 1388/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A servay effect of zinc on glycemic control in diabetic patients(type 1)
Public title
Effect of zinc adminesteration to controling of blood suger in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: type 1 diabetic patients; Exclusion criteria: sensitivity to zinc sulfate and HbA1C <6.5
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee, Ahvaz Jundishapur University
Street address
Ahvaz Jundishapur University of medical sciences.
City
Ahvaz
Postal code
Approval date
empty
Ethics committee reference number
236/د/20/8/پ

Health conditions studied

1

Description of health condition studied
Diabetes mellitus
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus

Primary outcomes

1

Description
HbA1c level
Timepoint
At the baseline and 3 month later
Method of measurement
HPLC method

Secondary outcomes

1

Description
Serum zinc
Timepoint
At the baseline and 3 month later
Method of measurement
atomic absorption spectrophotometry

Intervention groups

1

Description
Intervention:zinc 50 mg daily.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Atefe Hasanzade
Street address
Ahvaz Golestan hospital
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jundishapur University of Ahvaz-research deputy
Full name of responsible person
Dr Atefe Hasanzade
Street address
Ahvaz Jundishapur University of medical sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jundishapur University of Ahvaz-research deputy
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
Jundishapour university
Full name of responsible person
Dr Atefe Hasanzade
Position
Internal medicine resident
Other areas of specialty/work
Street address
Ahvaz jundishapour medical university
City
Ahvaz
Postal code
Phone
+98 916 300 3304
Fax
Email
atefehasanzade@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University
Full name of responsible person
Dr Peyman Payami
Position
Assistant professor of endocrine and metabolism
Other areas of specialty/work
Street address
Golestan hospital, internal medicine ward
City
Ahvaz
Postal code
Phone
+98 61 1441 3271
Fax
Email
peyman_payami1@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Dr Atefe Hasanzade
Position
Other areas of specialty/work
Street address
Golestan hospital
City
Ahwaz
Postal code
Phone
+98 61 1441 3271
Fax
Email
atefehasanzade@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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