Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of inofolic supplementation on metabolic profiles and gene expression related to insulin and lipid in patients with polycystic ovary syndrome (PCOS).
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Design
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Study design: Randomized controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive supplements (n=30) or control (n=30).
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Settings and conduct
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Among patients with gestational diabetes referred to Kosar outpatient Clinic affiliated to Arak University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Pregnancy, adrenal hyperplasia, androgen-secreting tumors, hyperprolactinemia, thyroid dysfunction, diabetes.
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Intervention groups
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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: Glycemic control (primary outcomes), lipid profiles, and gene expression related to insulin and lipid (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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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017082733941N10
Registration date:
2017-09-18, 1396/06/27
Registration timing:
retrospective
Last update:
2019-09-25, 1398/07/03
Update count:
1
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Registration date
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2017-09-18, 1396/06/27
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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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Vice chancellor for research, Arak University of Medical Sciences
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Expected recruitment start date
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2017-08-15, 1396/05/24
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Expected recruitment end date
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2017-08-30, 1396/06/08
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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 metabolic profiles and gene expression related to insulin and lipid in women with polycystic ovary syndrome
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Public title
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Effect of inofolic 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
Aged 18 to 40 years
Exclusion criteria:
Pregnancy
Adrenal hyperplasia
Androgen-secreting tumors
Hyperprolactinemia
Thyroid dysfunction
Diabetes
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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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N/A
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Groups that have been masked
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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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To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or control. Randomization will be done by the use of computer software.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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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2017-08-14, 1396/05/23
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Ethics committee reference number
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IR.ARAKMU.REC.1396.90
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
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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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Elisa kit
2
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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 12 weeks of intervention
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Method of measurement
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Calculation using HOMA formula
Secondary outcomes
1
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Description
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Total cholesterol
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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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Enzymatic kit
2
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Description
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HDL
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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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Enzymatic kit
3
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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 12 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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Expressed levels of PPAR-γ gene
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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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PCR
5
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Description
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Expressed levels of GLUT-1 gene
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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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PCR
6
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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 12 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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Expressed levels of LDLR gene
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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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PCR
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