The objective of this randomized double-blind placebo controlled trial is to investigate the effect of zinc sulfate complement on the metabolic and cardiovascular outcomes in Polycysitic ovarian syndrome (PCOS). Subjects with PSCO will be recruited from the infertility department of Alzahra hospital in Tabriz. Patients will be randomly assigned to receive either 220mg Zinc Sulfate oral capsule (50 mg/day elemental zinc) or cornstarch placebo capsules for 60 days. Anthropometric measurements (weight, height, waist and hip circumference, waist to hip ratio), blood pressure and biochemical parameters (lipid profile (total cholesterol, LDL and HDL cholesterol and triglyceride concentrations), fasting glucose and insulin level, IL-6 and hs-CRP levels, concentrations of serum zinc and androgens (DHEAS and testosterone), dietary data obtained from 3-day food records and food frequency questionnaire will be measured before and after treatment and compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138803212017N2
Registration date:2009-10-02, 1388/07/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-10-02, 1388/07/10
Registrant information
Name
Alireza Ostadrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
ostadrahimi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Tabriz University Of Medical Sciences
Expected recruitment start date
2009-04-04, 1388/01/15
Expected recruitment end date
2009-08-06, 1388/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of zinc supplementation on metabolic factors in patients with polycystic ovarian syndrome
Public title
Zinc supplementation in patients with polycystic ovarian syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Women with PCOS diagnosed by the Rotterdam consensus criteria (Presence of 2 of the following 3 conditions: i. Oligo/anovulation ii. clinical or biochemical evidence of hyperandrogenism iii. Polycystic ovaries on ultrasound examination), age 20-45 years, BMI ≥ 25, moderate activity
Exclusion criteria: Any disease that influence metabolic parameters in this trial (liver, cardiovascular, kidney or gastrointestinal diseases, hypo/hyper thyroidism, hyperprolactinemia, congenital adrenal hyperplasia, Cushing’s syndrome, androgen secreting tumors), insulin consumption, receiving antihypertension drugs, pregnancy, breast feeding, receiving any vitamin or mineral supplements, any special diet.
Age
From 20 years old to 45 years old
Gender
Female
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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University Of Medical Sciences
Street address
Tabriz University Of Medical Sciences, Attare Neishaboori Avenue, Golgasht Street, Tabriz-
Waist and hip circumference measure with a plastic tape meter.Body weight without shoes with calibrated scale accurate to 0.1 kg.Standing height without shoes or socks measureto the nearest 0.1 cm with a stadiometer mounted on a wall.BMI calculated with this equation:W(kg) /H(m)2. WHR calculated with waist circumference/hip circumference.
Intervention groups
1
Description
Zinc Sulfate one capsule a day for 8 weeks, (220 mg zinc sulphate capsule (50 mg elemental zinc)
Category
Treatment - Drugs
2
Description
Placebo one capsule a day for 8 weeks (insoluble corn starch)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital.Tabriz
Full name of responsible person
Fatemeh Pourteymour farde tbarizi
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
1) Vice-chancellor for research of Tabriz University of Medical Sciences 2)Tabriz Nutrition Researc
Full name of responsible person
Ali Reza Ostadrahimi
Street address
1) Tabriz University Of Medical Sciences, Tabriz, East Azarbaijan, Iran. 2) Nutrition research center, Golgasht street, Attare Neishabouri Avenue, Health and Nutrition School, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
1) Vice-chancellor for research of Tabriz University of Medical Sciences 2)Tabriz Nutrition Researc
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
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Pourteymour farde tabriz
Position
MS student in Nutrition
Other areas of specialty/work
Street address
Health and Nutrition school, Attare Neishabouri Avenue, Golgasht street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1334 0540
Fax
Email
fateme.pourteymour@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Pourteymour farde tabrizi
Position
MS student on Nutrition
Other areas of specialty/work
Street address
Health and Nutrition school, Attare Neishabouri Avenue, Golgasht street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1334 0540
Fax
Email
fateme.pourteymour@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Pourteymour farde tabrizi
Position
MS student on Nutrition
Other areas of specialty/work
Street address
Health and Nutrition school, Attare Neishabouri Avenue, Golgasht street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1334 0540
Fax
Email
fateme.pourteymour@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)