Clinical trial of the effect of combined vitamin D, K and calcium supplementation compared with the placebo on metabolic profiles in women with polycystic ovary syndrome
Objective: The aim of this study is to determine the effects of combined vitamin D, K and calcium supplementation on metabolic profiles in patients of polycystic ovary syndrome (PCOS). Study design: Parallel double-blind clinical trial. Blinding will be conducted both patients and researchers. 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 Akbarabadi Clinic affiliated to Iran University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive combined vitamin D, K and calcium (n=30) or placebo (n=30) every two weeks. Combined vitamin D, K and calcium and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 8 weeks after the intervention. At the beginning and end of the intervention: 2 months. Outcomes: Metabolic profiles will be quantified at study baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608115623N87
Registration date:2016-08-26, 1395/06/05
Registration timing:retrospective
Last update:
Update count:1
Registration date
2016-08-26, 1395/06/05
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
Iran University of Medical Sciences
Expected recruitment start date
2016-07-01, 1395/04/11
Expected recruitment end date
2016-07-08, 1395/04/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of combined vitamin D, K and calcium 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 PCOS according to Rotterdam criteria; aged 18 to 40 years.
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:
60
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 Iran University of Medical Sciences
Street address
Vice chancellor for research, Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Postal code
Approval date
2016-07-02, 1395/04/12
Ethics committee reference number
IR.IUMS.REC.1395.26361
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 resistance
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Questionnaire
2
Description
Serum insulin
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Elisa kit
Secondary outcomes
1
Description
Triglycerides
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
Total cholesterol
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
HDL
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit
Intervention groups
1
Description
Intervention group: Vitamin D, K and calcium supplements, 400 IU vitamin D+ 90 µg vitamin K+1000 mg calcium (Aryan Salamat, Tehran, Iran), daily, for 8 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule (Aryan Salamat, Tehran, Iran), daily for 8 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Clinic
Full name of responsible person
Maryam Karamali
Street address
Akbarabadi Hospital, Mowlavi Street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Moosavi
Street address
Vice chancellor for research, Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
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, Iran 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)