Objective: The aim of the current study is to evaluate the effects of vitamins D, K and calcium supplementation on metabolic profiles in women with polycystic ovary syndrome (PCOS). Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Inclusion and exclusion criteria: In the current study, women aged 18-40 years diagnosed with PCOS will be included. Individuals with neoplastic, cardiovascular disorders, malabsorptive disorders, current or previous (within the last 6 months) use of hormonal, anti-diabetic medications and anti-obesity medications will be excluded in the study. Population and sample size: 60 patients with PCOS among women of eligible and referred to Alavi Clinic affiliated to Ardabil University of Medical Sciences, Ardabil, Iran in the study will be selected. Intervention: Patients will be assigned to receive either vitamins D, K and calcium supplements (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 8 weeks of intervention to measure metabolic profiles. Start and end date of intervention: 8 weeks (August 11, 2015-October 11, 2015). Outcomes: Metabolic profiles will be measured at study baseline and after 8 weeks of intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509015623N51
Registration date:2015-09-09, 1394/06/18
Registration timing:na
Last update:
Update count:1
Registration date
2015-09-09, 1394/06/18
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
Not enough for processing
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2015-08-09, 1394/05/18
Expected recruitment end date
2005-08-11, 1384/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of combined vitamins D, K and calcium supplementation 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: Women aged 18-40 years; diagnosed with PCOS.
Exclusion criteria: Individuals with neoplastic; cardiovascular disorders; malabsorptive disorders; current or previous (within the last 6 months) use of hormonal; anti-diabetic medications; anti-obesity medications.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences
City
Ardabil
Postal code
Approval date
2015-08-08, 1394/05/17
Ethics committee reference number
IR.ARUMS.REC.1394.16
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 8 weeks of intervention
Method of measurement
Elisa kit
2
Description
Insulin resistance
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Questionnaire
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-cholesterol
Timepoint
At the beginning of the study and after 8 weeks of intervention