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 metabolic profiles 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) clinical trial. Randomization 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: Among patients with PCOS referred to Taleghani and Emam Reza Clinics affiliated to Arak University of Medical Sciences, 64 patients will be selected according to inclusion and eclusion criteria.
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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. Exclusion criteria: Women with hyperprolactinemia, diabetes mellitus, thyroid disease, adrenal hyperplasia, consumed effective drugs on hormonal profile, ovulation induction agents, consuming anti-obesity and antidepressant drugs in the last 3 months (before enrollment).
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Intervention groups
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Intervention: Patients will be assigned into two groups to receive 200 mcg chromium supplements (n=32) or placebo (n=32) daily. Chromium supplements and placebos capsules are similar in shape and size.
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Main outcome variables
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Markers of insulin metabolism (primary outcomes) and lipid profiles (secondary outcome)
General information
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Reason for update
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Due to an error, the request for an update in our website was conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201502055623N34
Registration date:
2015-02-09, 1393/11/20
Registration timing:
registered_while_recruiting
Last update:
2019-11-04, 1398/08/13
Update count:
1
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Registration date
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2015-02-09, 1393/11/20
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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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Arak University of Medical Sciences
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Expected recruitment start date
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2015-02-02, 1393/11/13
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Expected recruitment end date
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2015-03-01, 1393/12/10
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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 metabolic profiles 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:
Women with hyperprolactinemia
Diabetes mellitus
Thyroid disease
Adrenal hyperplasia
Consumed effective drugs on hormonal profile
Ovulation induction agents
Anti-obesity and antidepressants in the last 3 months before enrollment
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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 supplementation (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. Chromium supplements and placebos capsules are similar in shape and size.
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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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2015-02-01, 1393/11/12
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Ethics committee reference number
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93-174-21
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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Insulin resistance
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Timepoint
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At the beginning of the study and after 8 weeks of the intervention
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Method of measurement
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Calculation with HOMA formula
Secondary outcomes
1
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Description
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Insulin
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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ELISA kit
2
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Description
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Cholesterol
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
3
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Description
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HDL-cholesterol
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
4
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Description
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Triglycerides
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
5
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Description
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VLDL
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
6
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Description
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LDL
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
7
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Description
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FPG
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
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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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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Arak 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