Protocol summary
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Study aim
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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).
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Design
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Study design: parallel double-blind randomized controlled clinical trial.
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Settings and conduct
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Population and sample size: 64 women with PCOS eligible and referred to Alavi Clinic affiliated to Ardabil University of Medical Sciences, Ardabil, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with PCOS according to Rotterdam criteria and aged 18 to 40 years will be included in this study. Exclusion criteria: Elevated levels of prolactin, thyroid disorder T2DM, congenital adrenal hyperplasia, had normal baseline renal function tests, bilirubin, and aminotransferases, during the last 3 months before the intervention used anyform of oral contraceptives (OCPs), steroid hormones, or any other treatments likely to affect ovarian function, insulin sensitivity, or inflammatory factors, biomarkers of oxidative stress.
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Intervention groups
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Intervention: Patients will be assigned to receive either 200 µg selenium supplement (intervention group: n=32) or placebo (control group: n=32).
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Main outcome variables
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Outcomes: Malondialdehyde (primary outcomes) and Hormonal parameters and other metabolic profiles (secondary outcomes)
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201412295623N33
Registration date:
2015-01-09, 1393/10/19
Registration timing:
retrospective
Last update:
2019-09-25, 1398/07/03
Update count:
1
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Registration date
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2015-01-09, 1393/10/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Ardabil University of Medical Sciences
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Expected recruitment start date
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2014-10-19, 1393/07/27
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Expected recruitment end date
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2014-11-02, 1393/08/11
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effects of selenium supplementation on hormonal status and biomarkers of oxidative stress in women with polycystic ovary syndrome
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Public title
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Effect of supplementation in treatment of polycystic ovary syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women aged 18-40 years
Diagnosed with PCOS
Exclusion criteria:
Elevated levels of prolactin
Thyroid disorder
T2DM
Congenital adrenal hyperplasia
Had normal baseline renal function tests, bilirubin, and aminotransferases
During the last 3 months before the intervention used anyform of oral contraceptives (OCPs), steroid hormones, or any other treatments likely to affect ovarian function, insulin sensitivity, or inflammatory factors, biomarkers of oxidative stress.
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take selenium supplements (n=32) or placebo (n=32). Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2014-10-18, 1393/07/26
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Ethics committee reference number
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ARUMS.REC.1393.53
Health conditions studied
1
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Description of health condition studied
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Polycystic ovary syndrome
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ICD-10 code
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E28.2
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ICD-10 code description
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Polycystic ovarian syndrome
Primary outcomes
1
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Description
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Malondialdehyde
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
Secondary outcomes
1
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Description
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Prolactin
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Elisa
2
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Description
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FSH
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Elisa
3
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Description
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LH
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Elisa
4
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Description
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Free testosterone
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Elisa kit
5
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Description
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Hs-CRP
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Elisa kit
6
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Description
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Total antioxidant
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
7
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Description
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Glutathione
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
8
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Description
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Nitric oxide
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
Intervention groups
1
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Description
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Control group: Placebo tablet, daily, for 8 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Selenium tablet, 200 µg, daily, for 8 weeks orally.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ardabil University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available