The aim of this study is to evaluate the effect of vitamin D3 supplementation on glycemic parameters, lipid profile and hs-CRP inflammatory factor in polycystic ovarian syndrome (PCOS). Fifty women with PCOS who are 18-40 years old and meet the inclusion criteria would be recruited from clinics of Tabriz University of medical sciences. The patients are assigned as a double blind manner into placebo or intervention groups based on age and whether consume drugs. The intervention group receive oral vitamin D3 supplement one tablet every 20 days for 60 days (50000 IU vitamin D3/tablet) and the placebo group receive placebo in the same way. 24h dietary recall for 3 days, anthropometric indices, fasting blood sager, insulin, triglycerides, lipoproteins, Apo A-1, 25(OH)D, parathyroid hormone and hs-CRP are measured at baseline and after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904113140N2
Registration date:2010-07-02, 1389/04/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-07-02, 1389/04/11
Registrant information
Name
Bahram Pourghassem Gargari
Name of organization / entity
Health and Nutrition Faculty, Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1435 7580
Email address
pourghassemb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz university of medical sciences, Nutrition research committee
Expected recruitment start date
2010-04-19, 1389/01/30
Expected recruitment end date
2010-08-09, 1389/05/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral vitamin D3 supplementation on glycemic parameters, lipid profile, and hs-CRP inflammatory factor in polycystic ovarian syndrome
Public title
Effect of vitamin D3 supplementation on polycystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of PCOS based on Rotterdam criteria (presence of two of the three following characteristics: 1. oligomemorreha /amenorrhea, 2. chemical or clinical finding of hyperandrogenism and 3. polycystic appearance of ovary), voluntary consent for participation in the study, age of 16-40 years, gender: female. Exclusion criteria: Other common causes of hyperandrogenemia and/or anovulation; hyperprolactinoma, congenital adrenal hyperplasia, Cushing syndrome, and virilizing ovarian or adrenal tumors, diabetes mellitus and heart, kidney and liver dysfunction, using vitamin D or Calcium supplement, metformin or insulin sensitizing drugs, corticosteroids, anticonvulsants during last 2 month or during the study, Smoking, alcohol abuse, breast feeding and pregnancy.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This study would be done in spring and summer which vitamin D effective UV radiation is the same in 38th latitude.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz university of medical sciences
Street address
Tabriz university of medical sciences
City
Tabriz
Postal code
Approval date
empty
Ethics committee reference number
8911
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
improvement of gelycemic parameters
Timepoint
60 days
Method of measurement
serum level of blood suger and fasting Insulin
2
Description
lipid profile and hs-CRP
Timepoint
60 days
Method of measurement
Serum level of HDL, LDL, Total Cholesterol, TG, ApoA1, hs-CRP
3
Description
serum level of alkaline phosphatase, calcium and phosphorus
Timepoint
60 days
Method of measurement
serum level
Secondary outcomes
1
Description
antropometric indicators (BMI)
Timepoint
60 days
Method of measurement
Body weight without shoes with calibrated scale, Standing height without shoes are measuredl. BMI was calculated with this equation: W(kg) /H(m)2.
2
Description
dietary regime
Timepoint
60 days
Method of measurement
3 days 24h dietaty racall
Intervention groups
1
Description
intervantion group: 50000 IU vitaminD3 every 20 days for 60 days
Category
Treatment - Drugs
2
Description
control group: placebo every 20 days for 60 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital and Pardis clinic
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice-chancellor of Tabriz University of Medical Sciences and Nutrition Research Center of T
Full name of responsible person
Dr Rashidi and Dr Ostadrahimi
Street address
Health & Nutrition Faculty, Tabriz university of medical sciences, 3rd floor, Golgasht st, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice-chancellor of Tabriz University of Medical Sciences and Nutrition Research Center of T
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
Name of organization / entity
Health and Nutrition Faculty, Tabriz university of medical sciences
Full name of responsible person
Bahram Pourghassem
Position
PhD in Nutrition science
Other areas of specialty/work
Street address
Health and Nutrition Faculty of Tabriz
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
pourghassemb@tbzmed.ac.ir & bahrampg@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Health and Nutrition Faculty, Tabriz university of medical sciences
Full name of responsible person
Bahram Pourghassem Gargari
Position
PhD in Nutrition science
Other areas of specialty/work
Street address
Health and Nutrition Faculty
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
pourghassemb@tbzmed.ac.ir & bahrampg@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Health and Nutrition faculty, Tabriz university of medical sciences
Full name of responsible person
Hania Rahimi
Position
Master student of nutrition science
Other areas of specialty/work
Street address
Health and Nutrition faculty
City
Tabriz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)