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 and calcium co-supplementation on insulin resistance and lipid factors in overweight women with polycystic ovary syndrome (PCOS).
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Design
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Study design: parallel double-blind randomized controlled clinical trial.
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Settings and conduct
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Population and sample size: 104 women with PCOS eligible and referred to Gynecology Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with PCOS according to Rotterdam criteria and aged 18 to 40 years will be included in this study. Exclusion criteria: Neoplastic, hepatic disorders, renal or cardiovascular disorders, malabsorptive disorders, taking calcium and vitamin D within the last 6 months, calcium intake more than 1500 mg per day, using hormone therapy, antidiabetic, or anti-obesity medications within the last 6 months.
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Intervention groups
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Intervention: Patients will be assigned to receive either 50000 IU vitamin D/week and 1000 mg calcium/d co-supplement (intervention group: n=26), 50000 IU vitamin D/week supplement (intervention group: n=26), 1000 mg/d calcium supplement (intervention group: n=26) or placebo (control group: n=26).
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Main outcome variables
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Insulin resistance (primary outcome) and lipid profiles (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:
IRCT201309275623N10
Registration date:
2013-10-07, 1392/07/15
Registration timing:
registered_while_recruiting
Last update:
2019-10-20, 1398/07/28
Update count:
1
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Registration date
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2013-10-07, 1392/07/15
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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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Kashan University of Medical Sciences
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Expected recruitment start date
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2013-10-02, 1392/07/10
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Expected recruitment end date
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2013-10-16, 1392/07/24
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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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Effects of vitamin D and calcium co-supplementation on insulin resistance and lipid factor in overweight women with polycystic ovary syndrome
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Public title
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Effect of supplementation in treatment of 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:
Neoplastic
Hepatic disorders
Renal or cardiovascular disorders
Malabsorptive disorders
Taking calcium and vitamin D within the last 6 months
Calcium intake more than 1500 mg per day
Using hormone therapy, antidiabetic, or anti-obesity medications within the last 6 months
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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:
104
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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 at study baseline and after stratification for pre-intervention BMI and age will be randomly allocated to take either supplement or placebo. Randomization will be done by the use of Stat Trek 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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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Clinic who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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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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2013-10-01, 1392/07/09
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Ethics committee reference number
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P/29/5/1/2588
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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Sclerocystic ovary syndrome Stein-Leventhal syndrome
Primary outcomes
1
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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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Eliza
Secondary 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 sensitivity
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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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Using QUICKI formula
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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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
5
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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 8 weeks of intervention
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Method of measurement
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Enzymatic kit
6
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Description
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LDL-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
7
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Description
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HDL-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
Intervention groups
1
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Description
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Intervention group: Vitamin D perl and calcium capsule, 50000 IU and 1000 mg, weekly and daily, 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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Intervention group: Vitamin D perl, 50000 IU, weekly, for 8 weeks orally.
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Category
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Treatment - Drugs
3
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Description
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Intervention group: Calcium capsule, 1000 mg, daily, for 8 weeks orally.
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Category
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Treatment - Drugs
4
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Description
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Control group: Placebo capsule, daily, for 8 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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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