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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General information
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18
2018
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6540
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The updating process was done after publishing the paper to correct the registration information.
The updating process was done after publishing the paper to correct the registration information.
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پروسه بروزرسانی پس از انتشار مقاله به منظور تصحیح اطلاعات ثبت انجام گرفت.
پروسه بروزرسانی پس از انتشار مقاله به منظور تصحیح اطلاعات ثبت انجام گرفت.
Protocol summary
Study aim
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).
Design
Study design: Parallel clinical trial. Randomization will be done by the use of computer-generated random numbers.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
Intervention: Patients will be assigned into two groups to receive inofolic (n=30) or metformin (n=30).
Main outcome variables
Outcomes: Parameters of mental health (primary outcomes) and oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Reason for update
The updating process was done after publishing the paper to correct the registration information.
Acronym
IRCT registration information
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
Registration date
2017-07-04, 1396/04/13
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
Arak University of Medical Sciences
Expected recruitment start date
2016-06-14, 1395/03/25
Expected recruitment end date
2016-07-17, 1395/04/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of supplementation in treatment of women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2016-06-13, 1395/03/24
Ethics committee reference number
IR.ARAKMU.REC.1395.110
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Beck scor
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
2
Description
GHQ score
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
3
Description
DASS-28 score
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
2
Description
Total glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention