Protocol summary
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Study aim
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The aim of this study is to determine the effects of inofolic supplementation compared with metformin on parameters of mental health and oxidative stress in patients of polycystic ovary syndrome (PCOS).
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Design
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Study design: Parallel 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 Kosar Clinic affiliated to Arak University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with PCOS according to Rotterdam criteria will be included in this study. Exclusion criteria: The intake of folate supplements within the last 3 months, pregnant women, individuals with metabolic diseases, thyroid disease, hyperprolactinemia and hypercortisolemia.
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Intervention groups
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Intervention: Patients will be assigned into two groups to receive inofolic (n=30) or metformin (n=30).
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Main outcome variables
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Outcomes: Parameters of mental health (primary outcomes) and oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
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Reason for update
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The updating process was done after publishing the paper to correct the registration information.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201706065623N118
Registration date:
2017-07-04, 1396/04/13
Registration timing:
retrospective
Last update:
2023-04-05, 1402/01/16
Update count:
2
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Registration date
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2017-07-04, 1396/04/13
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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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2016-06-14, 1395/03/25
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Expected recruitment end date
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2016-07-17, 1395/04/27
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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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Clinical trial of the effect of inofolic supplementation compared with metformin on parameters of mental health and oxidative stress in women with polycystic ovary syndrome
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Public title
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Effect of supplementation in treatment of women with 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:
Patients with PCOS according to Rotterdam criteria
Exclusion criteria:
Smokers
The intake of folate supplements within the last 3 months
Pregnant women
Individuals with metabolic diseases
Thyroid disease
Hyperprolactinemia and hypercortisolemia
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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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No information
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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 and after balanced blocked randomization, subjects will be randomly divided into two groups to take either inofolic supplementation or metformin. Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2016-06-13, 1395/03/24
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Ethics committee reference number
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IR.ARAKMU.REC.1395.110
Health conditions studied
1
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Description of health condition studied
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Polycystic ovarian 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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Beck scor
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Questionnaire
2
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Description
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GHQ score
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Questionnaire
3
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Description
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DASS-28 score
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Questionnaire
Secondary outcomes
1
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Description
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Total antioxidant capacity
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
2
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Description
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Total glutathione
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
3
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Description
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Malondialdehyde
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
Intervention groups
1
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Description
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Intervention group: Inofolic supplements (Loli, Rome, Italy), 2000 mg myo-inositol, 200 µg folic acid, twice a day, for 12 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: Metformin tablet (Tehran Darou,Tehran, Iran), according to the patient's tolerance, daily for 12 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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Vice chancellor for research, 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