The objective of this study is to investigate the effect of zinc supplementation on proteinuria and sexual function in patient with Type II Diaberes Mellitus. In this randomized placebo controlled cross over trial, 50 male diabetic patients with microalbuminuria are enrolled. Patients will be randomly assigned into two groups (25 in each of two groups) to receive 30 mg elemental zinc or placebo for 3 months. After a four- week washout period, the groups will cross-over and the protocol will be repeated. Fasting plasma glucose (FBS), HbA1C, lipid profiles, random urine for albumin and creatinine (AC Ratio), GFR, and plasma zinc and testosterone levels will be measured before and after each period. Patients’ sexual function will be determined with International Index of Erectile Function-5 (IIEF-5).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138806091179N3
Registration date:2011-03-20, 1389/12/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-03-20, 1389/12/29
Registrant information
Name
Faranak Sharifi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 1727 0815
Email address
zmdrc@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Metabolic Diseases Research Center, Zanjan University of Medical Sciences
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-08-22, 1389/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of zinc supplementation on proteinuria and sexual function in patients with Type II Diabetes Mellitus
Public title
Effect of zinc supplementation on proteinuria and sexual function in patients with Type II Diabetes Mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Confirmed continuous albuminuria
Exclusion criteria: Intake of any kind of vitamin supplements in recent months, Active urinary tract infections, increased liver enzymes more than 2 times, Allergic reactions to zinc, Failure to follow up, Any history of systemic inflammatory disorders or active infection, GFR below 30 ml / min, Hypogonadysm due to other reasons, Existence of proteinuria due to other reasons
Age
From 30 years old to 70 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences, Ethical Committee
Street address
Azadi Boulevard
City
Zanjan
Postal code
77978-45157
Approval date
2009-07-29, 1388/05/07
Ethics committee reference number
1617/3-3/19
Health conditions studied
1
Description of health condition studied
Diabetic Nephropathy
ICD-10 code
E10, E11,
ICD-10 code description
Primary outcomes
1
Description
Microalbominuria
Timepoint
at the beginning of the study and 3 months after intervention
Method of measurement
Immuno Turbidomethry
Secondary outcomes
1
Description
Glomerular Filtration Rate
Timepoint
at the begining of the study and 3month after intervention
Method of measurement
Based on this formula:GFR=140-BW×Age/p×72
2
Description
Sexual Function
Timepoint
at the beginning of the study and 3month after intervention
Method of measurement
Based on IIEF-5 questionnaire
Intervention groups
1
Description
placebo for three months
Category
Placebo
2
Description
cap zinc sulfate : 30mg/daily for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrine Clinic of Zanjan, Vali -e-Asr Hospital
Full name of responsible person
Dr. Faranak Sharifi
Street address
Vali-e-Asr Hospital, Zanjan , Iran
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan Metabolic Diseases Research Center, Zanjan University of Medical Sciences
Full name of responsible person
Dr. Alireza Biglari
Street address
Azadi Boulevard
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan Metabolic Diseases Research Center, Zanjan University of Medical Sciences