Objective: The aim of this study is to determine the effects of zinc supplementation on insulin resistance and inflammatory factor in women with polycystic ovary syndrome (PCOS). Study design: parallel double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Women aged 18-35 years diagnosed with PCOS will be included in this study. Individuals with neoplastic, cardiovascular disorders, malabsorptive disorders, current or previous (within the last 6 months) use of hormonal, antidiabetic medications and anti-obesity medications will be excluded in the study. Population and sample size: 60 women with PCOS eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either 50 mg zinc supplement (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 8-wk intervention to measure metabolic profiles and inflammatory factor. Start and End Date of Intervention: 8 weeks (June 10, 2014-August 10, 2014). Outcomes: Baseline and End-of-trial fasting plasma glucose (FPG), serum insulin, lipid profiles and hs-CRP levels.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406075623N19
Registration date:2014-07-16, 1393/04/25
Registration timing:retrospective
Last update:
Update count:1
Registration date
2014-07-16, 1393/04/25
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-07-16, 1393/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of zinc supplementation on insulin resistance and inflammatory factor in women with polycystic ovary syndrome
Public title
Effect of supplementation in treatment of polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Women aged 18-35 years; diagnosed with PCOS.
Exclusion Criteria: Individuals with neoplastic; cardiovascular disorders; malabsorptive disorders; current or previous (within the last 6 months) use of hormonal; antidiabetic medications; anti-obesity medications.