Objective: The aim of this study is to determine the effects of selenium supplementation on hormonal status and biomarkers of oxidative stress 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: 62 women with PCOS eligible and referred to Alavi Clinic affiliated to Ardabil University of Medical Sciences, Ardabil, Iran in the study will be selected. Intervention: Patients will be assigned to receive either 200 µg selenium supplement (intervention group: n=31) or placebo (control group: n=31). Fasting blood samples will be taken at baseline and after 8-wk intervention to measure hormonal status and biomarkers of oxidative stress. Start and End Date of Intervention: 8 weeks (October 1, 2014-December 30, 2014). Outcomes: Hormonal parameters and biomarkers of oxidative stress in baseline and end-of-trial will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412295623N33
Registration date:2015-01-09, 1393/10/19
Registration timing:retrospective
Last update:
Update count:1
Registration date
2015-01-09, 1393/10/19
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
Ardabil University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2014-10-31, 1393/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of selenium supplementation on hormonal status and biomarkers of oxidative stress 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
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
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
Ardabil University of Medical Sciences
Street address
Research Assistance, Ardabil University of Medical Sciences, Ardabil, Iran
City
Ardabil
Postal code
Approval date
2014-10-18, 1393/07/26
Ethics committee reference number
ARUMS.REC.1393.53
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Glutathione
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
2
Description
Total antioxidant capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
3
Description
LH
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
4
Description
Prolactin
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
5
Description
FSH
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
6
Description
Malondialdehyde
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
7
Description
Nitric oxide
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
8
Description
Testosterone
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Placebo tablet, daily, for 8 weeks orally.