Objective: The aim of this study is to determine the effects of vitamin D and calcium co-supplementation on insulin resistance and inflammatory factor in overweight women with polycystic ovary syndrome (PCOS). Study design: parallel double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Women aged 18-35 years with overweight 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: 120 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 50000 IU vitamin D/week and 1000 mg calcium/d co-supplement (intervention group: n=30), 50000 IU vitamin D/week supplement (intervention group: n=30), 1000 mg/d calcium 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 (September 30, 2013-November 30, 2013). 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:IRCT201309275623N10
Registration date:2013-10-07, 1392/07/15
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2013-10-07, 1392/07/15
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
2013-09-30, 1392/07/08
Expected recruitment end date
2013-11-29, 1392/09/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of vitamin D and calcium co-supplementation on insulin resistance and inflammatory factor in overweight 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.