Protocol summary
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Study aim
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Objective: the aim of this study is to determine the effects of chromium supplementation on hormonal status in women with polycystic ovary syndrome (PCOS).
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Design
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Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.
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Settings and conduct
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Population and sample size: 60 women with PCOS eligible and referred to Endocrinology and Gynecology Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Women aged 18-40 years old diagnosed with PCOS.
Exclusion criteria: Individuals with elevated levels of prolactin, thyroid disorder, endocrine diseases including diabetes or impaired glucose tolerance, gastrointestinal problems.
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Intervention groups
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Intervention group: Chromium tablet, 200 µg, daily, for 8 weeks orally.
Control group: Placebo tablet, daily, for 8 weeks orally.
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Main outcome variables
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Outcomes: Free testosterone (primary outcome), and other hormonal profiles, biomarkers of inflammation and oxidative stress (secondry outcomes) will be quantified at the study baseline and end-of-trial.
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:
IRCT201506105623N44
Registration date:
2015-06-27, 1394/04/06
Registration timing:
registered_while_recruiting
Last update:
2019-10-01, 1398/07/09
Update count:
1
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Registration date
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2015-06-27, 1394/04/06
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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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Kashan University of Medical Sciences
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Expected recruitment start date
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2015-06-22, 1394/04/01
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Expected recruitment end date
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2015-07-02, 1394/04/11
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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 chromium supplementation on hormonal status 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 old diagnosed with PCOS
Exclusion criteria:
Individuals with elevated levels of prolactin
Thyroid disorder
Endocrine diseases including diabetes or impaired glucose tolerance
Gastrointestinal problems
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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:
60
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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, after balanced blocked randomisation, subjects will be allocated into two groups to take supplements (n = 30) or placebo (n = 30). 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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2015-06-02, 1394/03/12
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Ethics committee reference number
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IR.Kaums.REC.1394.33
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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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
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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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
5
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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
6
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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
7
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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
8
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Description
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17-OH progesterone
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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
9
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Description
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DHEA
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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
Intervention groups
1
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Description
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Intervention group: Chromium tablet, 200 µg, 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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Control group: Placebo tablet, daily, for 8 weeks orally.
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Category
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Placebo
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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Kashan 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