Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of vitamin D supplementation on metabolic profiles and gene expression related to insulin and lipid in patients with polycystic ovary syndrome candidate for IVF.
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Design
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Study design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive vitamin D supplements (n=20) or placebo (n=20).
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Settings and conduct
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Among patients with polycystic ovary syndrome candidate for IVF referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, 40 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 8 weeks after the intervention. At the beginning and the end of the intervention: 8 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with polycystic ovary syndrome candidate for IVF aged 18 to 40 years. Exclusion criteria: Thyroid disorder, diabetes or impaired glucose tolerance.
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Intervention groups
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Intervention group: 50000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 8 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran) every 2 weeks, for 8 weeks orally.
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Main outcome variables
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Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles and gene expression related to insulin and lipid (secondary outcomes) 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:
IRCT20170513033941N27
Registration date:
2018-01-15, 1396/10/25
Registration timing:
retrospective
Last update:
2019-09-15, 1398/06/24
Update count:
1
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Registration date
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2018-01-15, 1396/10/25
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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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Expected recruitment start date
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2017-12-26, 1396/10/05
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Expected recruitment end date
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2018-01-10, 1396/10/20
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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 metabolic profiles and gene expression related to insulin and lipid in women with polycystic ovary syndrome candidate for IVF
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Public title
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Effect of vitamin D supplementation in treatment of patients with polycystic ovary syndrome candidate for IVF
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Inclusion criteria: Patients with polycystic ovary syndrome.
Individuals aged 18 to 40 years.
Exclusion criteria:
Thyroid disorder
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:
40
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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, after balanced randomisation, subjects will be allocated into two groups to receive supplement or placebo. 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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2017-12-25, 1396/10/04
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1396.88
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 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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Insulin resistance
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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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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 8 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 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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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
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 8 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 8 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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Expressed levels of LDL-R gene
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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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PCR
Intervention groups
1
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Description
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Intervention group: 50000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), 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 (Barij Essence, Kashan, Iran) every 2 weeks, for 8 weeks orally.
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Category
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Placebo
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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Kashan 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