Protocol summary
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Study aim
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The aim of this study is to determine the effects of vitamin D supplementation on biomarkers of inflammation and oxidative stress in patients of polycystic ovary syndrome (PCOS) with insulin resistance.
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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 Kosar Clinic affiliated to Arak University of Medical Sciences, 90 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 aged 18 to 40 years. Exclusion criteria: Pregnant during the intervention, androgen secreting tumors, hyperprolactinemia, thyroid dysfunction, diabetes or impaired glucose tolerance.
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Intervention groups
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Intervention: Patients will be assigned into three groups to receive vitamin D with dosage of 4000 IU (n=30) or vitamin D with dosage of 1000 IU (n=30) or placebo (n=30). Vitamin D supplements and placebos capsules are similar in shape and size.
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Main outcome variables
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Outcomes: Hormonal profiles (primary outcomes) and biomarkers of inflammation 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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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:
IRCT201604145623N75
Registration date:
2016-04-20, 1395/02/01
Registration timing:
retrospective
Last update:
2019-10-18, 1398/07/26
Update count:
1
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Registration date
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2016-04-20, 1395/02/01
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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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2016-03-07, 1394/12/17
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Expected recruitment end date
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2016-03-15, 1394/12/25
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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 vitamin D supplementation compared with the placebo on biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome
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Public title
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Effect of vitamin D 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:
Pregnant during the intervention
Androgen secreting tumors
Hyperprolactinemia
Thyroid dysfunction
Diabetes or impaired glucose tolerance
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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:
90
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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 three groups. 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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2016-03-07, 1394/12/17
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Ethics committee reference number
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IR.ARAKMU.REC.1394.347
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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Total testosterone
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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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Sex hormone-binding globulin
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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
Secondary outcomes
1
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Description
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Total antioxidant
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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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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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Hs-CRP
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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
4
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Description
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Nitric oxide
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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
5
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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
6
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Description
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Hirsutism
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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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Clinical observation
7
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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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Enzymatic kit
Intervention groups
1
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Description
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Intervention group: Vitamin D supplements, 4000 IU, daily, 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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Intervention group: Vitamin D supplements, 1000 IU, daily, for 12 weeks orally.
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Category
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Treatment - Drugs
3
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Description
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Control group: Placebo capsule, 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