Objective: The aim of this study is to determine the effects of chromium supplementation on metabolic profiles in women with polycystic ovary syndrome (PCOS). Study design: parallel double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Women aged 18-40 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 Kossar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either 200 µg chromium 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. Start and End Date of Intervention: 8 weeks (February 20, 2015-April 20, 2015). Outcomes: Fasting plasma glucose, insulin, triglycerides, total cholesterol, LDL-C and HDL-C levels in baseline and end-of-trial will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502055623N34
Registration date:2015-02-09, 1393/11/20
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2015-02-09, 1393/11/20
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
Arak University of Medical Sciences
Expected recruitment start date
2015-01-30, 1393/11/10
Expected recruitment end date
2015-02-19, 1393/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of chromium supplementation on metabolic profiles 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 18-40 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.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
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
Arak University of Medical Sciences
Street address
Vice-chancellor for Education and Research, Sardasht Avenue, Arak