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 inflammatory factors and biomarkers of oxidative stress in overweight and deficient vitamin D 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 Kossar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with polycystic ovary syndrome and aged 18 to 40 years will be included in this study. Exclusion criteria: Pregnant or lactating women, taking medicinal treatment of infertility, individuals with diabetes mellitus, taking insulin-sensitizing agents and hormonal treatment involving oestrogen or progesterone within the last 3 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). Fasting blood samples will be taken at baseline and after 8-wk intervention to measure inflammatory factors and biomarkers of oxidative stress. Start and End Date of Intervention: 8 weeks.
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Main outcome variables
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Outcomes: HOMA-B (primary outcome) and biomarkers of inflammation and oxidative stress (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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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:
IRCT201407015623N21
Registration date:
2014-08-24, 1393/06/02
Registration timing:
retrospective
Last update:
2019-10-17, 1398/07/25
Update count:
1
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Registration date
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2014-08-24, 1393/06/02
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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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2014-05-22, 1393/03/01
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Expected recruitment end date
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2014-06-04, 1393/03/14
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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 inflammatory factors and biomarkers of oxidative stress in overweight and deficient vitamin D 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
Overweight (BMI ≥25 kg/m2)
Exclusion criteria:
Pregnant or lactating women
Taking medicinal treatment of infertility
Individuals with diabetes mellitus
Taking insulin-sensitizing agents and hormonal treatment involving oestrogen or progesterone within the last 3 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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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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2014-05-21, 1393/02/31
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Ethics committee reference number
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93-166-15
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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HOMA-B
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Elisa
Secondary outcomes
1
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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 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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Plasma malondialdehyde
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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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Spectrophotometry
3
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Description
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Plasma total antioxidant capacity
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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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Spectrophotometry
4
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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 8 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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Nitric oxide
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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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Spectrophotometry
6
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Description
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Catalase
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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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Spectrophotometry
Intervention groups
1
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Description
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Intervention group: Vitamin D pearl 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 pearl, 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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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