Objective: The aim of this study is to determine the effects of vitamin D supplementation on metabolic profiles in patients of polycystic ovary syndrome (PCOS). Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with PCOS according to Rotterdam criteria aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with PCOS referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 70 patients will be selected according to inclusion and eclusion criteria. Intervention: Patients will be assigned into two groups to receive vitamin D with dosage of 50000 IU (n=35) or placebo (n=35) every two weeks. Vitamin D supplements and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 3 months. Outcomes: Metabolic profiles will be quantifid at study baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201606115623N82
Registration date:2016-07-01, 1395/04/11
Registration timing:retrospective
Last update:
Update count:1
Registration date
2016-07-01, 1395/04/11
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-05-04, 1395/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of vitamin D supplementation compared with the placebo on metabolic profiles in women with polycystic ovary syndrome
Public title
Effect of supplementation in treatment of women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with phenotype B of PCOS according to Rotterdam criteria; aged between18 to 40 years old.
Exclusion criteria: Unwillingness to cooperate.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization will be done by the use of computer-generated random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Postal code
Approval date
2016-04-23, 1395/02/04
Ethics committee reference number
IR.ARAKMU.REC.1395.41
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
2
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Total antioxidant
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
2
Description
Cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
5
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
Intervention groups
1
Description
Intervention group: Vitamin D supplements, 50000 IU, every two weeks, for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule, every two weeks for 12 weeks orally.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Clinic
Full name of responsible person
Maryam Maktabi
Street address
Emam Khomeyni Avenue, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Mohammad Rafiee
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)